U.S. patent application number 16/136123 was filed with the patent office on 2019-03-21 for prosthetic valve with overlapping atrial tissue anchors and ventricular tissue anchors.
This patent application is currently assigned to CARDIOVALVE LTD.. The applicant listed for this patent is CARDIOVALVE LTD.. Invention is credited to Aviram BAUM, Boaz HARARI, Ilia HARITON, Meni IAMBERGER.
Application Number | 20190083253 16/136123 |
Document ID | / |
Family ID | 65719087 |
Filed Date | 2019-03-21 |
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United States Patent
Application |
20190083253 |
Kind Code |
A1 |
HARITON; Ilia ; et
al. |
March 21, 2019 |
PROSTHETIC VALVE WITH OVERLAPPING ATRIAL TISSUE ANCHORS AND
VENTRICULAR TISSUE ANCHORS
Abstract
A prosthetic valve for implantation within a native heart valve
may be provided. The prosthetic valve may include an annular outer
frame having a plurality of ventricular anchoring legs extending
therefrom, as well as an inner frame having a plurality of atrial
anchoring arms extending therefrom. A portion of each ventricular
anchoring leg may be configured to overlap with a portion of each
atrial anchoring arm in a common lateral plane. As a result, a
prosthetic valve with a reduced axial length may be provided.
Inventors: |
HARITON; Ilia; (Zichron
Yaackov, IL) ; IAMBERGER; Meni; (Kfar Saba, IL)
; BAUM; Aviram; (Tel Aviv, IL) ; HARARI; Boaz;
(Ganey Tikva, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CARDIOVALVE LTD. |
Or Yehuda |
|
IL |
|
|
Assignee: |
CARDIOVALVE LTD.
|
Family ID: |
65719087 |
Appl. No.: |
16/136123 |
Filed: |
September 19, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62560384 |
Sep 19, 2017 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/246 20130101;
A61F 2/2436 20130101; A61F 2/2454 20130101; A61F 2/2418 20130101;
A61F 2/243 20130101; A61F 2/2445 20130101; A61F 2220/0008 20130101;
A61F 2250/007 20130101; A61F 2/2463 20130101; A61F 2/2466 20130101;
A61F 2/2427 20130101; A61F 2210/0014 20130101; A61F 2/2409
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A prosthetic valve for implantation within a native heart valve,
the prosthetic valve comprising: an annular outer frame having a
plurality of ventricular anchoring legs configured to extend
therefrom; and an inner frame positioned at least partially within
the annular outer frame, the inner frame having a plurality of
atrial anchoring arms configured to extend therefrom, wherein a
portion of each of the plurality of ventricular anchoring legs is
configured to overlap with a portion of each of the plurality of
atrial anchoring arms in a common lateral plane.
2. The prosthetic valve of claim 1, wherein the common lateral
plane is perpendicular to a longitudinal axis of the prosthetic
valve.
3. The prosthetic valve of claim 1, wherein the atrial anchoring
arms and ventricular anchoring legs are configured to extend
radially outward from the inner frame and from the annular outer
frame, respectively.
4. The prosthetic valve of claim 1, wherein the prosthetic valve
has an axial length of two centimeters or less.
5. The prosthetic valve of claim 1, wherein the prosthetic valve is
configured to protrude a distance of 15 millimeters or less into a
ventricle of the heart when the prosthetic valve is implanted
within the native heart valve.
6. The prosthetic valve of claim 1, wherein an entire length of at
least one ventricular anchoring leg is configured to extend in a
non-ventricular direction.
7. The prosthetic valve of claim 1, wherein at least one atrial
anchoring arm includes: a first portion configured to extend in an
atrial direction; and a second portion configured to extend in a
ventricular direction.
8. The prosthetic valve of claim 1, wherein a diameter defined by
terminal ends of the atrial anchoring arms is at least twice as
large as a diameter of an inlet opening of the inner frame.
9. The prosthetic valve of claim 1, wherein an axial length of the
prosthetic valve is at least as large as a radius of an inlet
opening of the inner frame.
10. The prosthetic valve of claim 1, wherein an axial length of the
inner frame is at least as large as a radius of an inlet opening of
the inner frame.
11. The prosthetic valve of claim 1, further comprising: a
plurality of leaflets secured within the inner frame, at least one
of the leaflets having a radius of between thirteen and fifteen
millimeters.
12. The prosthetic valve of claim 11, wherein an axial length of
the prosthetic valve is at least as large as the radius of at least
one of the leaflets secured within the inner frame.
13. The prosthetic valve of claim 11, wherein an axial length of
the inner frame is at least as large as a radius of at least one of
the leaflets secured within the inner frame.
14. The prosthetic valve of claim 1, wherein a diameter defined by
terminal ends of the atrial anchoring arms is at least 1.2 times
larger than a diameter defined by terminal ends of the ventricular
anchoring legs.
15. The prosthetic valve of claim 1, wherein a diameter defined by
terminal ends of the atrial anchoring arms is at least 2.5 times
larger than an axial length of the prosthetic valve.
16. The prosthetic valve of claim 15, wherein the diameter defined
by the terminal ends of the atrial anchoring arms is between 2.6
and 2.9 times larger than the axial length of the prosthetic
valve.
17. The prosthetic valve of claim 1, wherein the inner frame has a
greater axial length than the annular outer frame.
18. The prosthetic valve of claim 1, wherein a portion of at least
one ventricular anchoring leg is configured to be substantially
aligned in a common lateral plane with an atrial end of the inner
frame.
19. The prosthetic valve of claim 1, wherein at least one
ventricular anchoring leg is configured to extend from a single
portion of the annular outer frame, and wherein none of the
ventricular anchoring legs share a common connection point to the
annular outer frame.
20. The prosthetic valve of claim 1, wherein at least one atrial
anchoring arm is configured to extend from a single portion of the
inner frame, and wherein none of the atrial anchoring arms share a
common connection point to the inner frame.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority from U.S. Provisional
Patent Application No. 62/560,384, filed Sep. 19, 2017, which is
hereby incorporated by reference in its entirety.
TECHNICAL FIELD
[0002] This disclosure relates generally to prosthetic valves and
delivery systems for prosthetic valves. More specifically, this
disclosure relates to prosthetic heart valves and methods
thereof.
BACKGROUND
[0003] The native heart valves (the tricuspid valve, pulmonary
valve, mitral valve, and aortic valve) play an important role in
regulating flow of blood through the cardiovascular system.
However, the native heart valves may become damaged or impaired due
to, for example, cardiovascular diseases, infections, or congenital
malformations, thus limiting the ability of the native heart valves
to regulate blood flow. This deficiency may result in reduced
cardiovascular function or even death.
[0004] To treat these conditions, prosthetic heart valves may be
implanted at or near the site of a damaged or impaired native
valve. A prosthetic heart valve may assist or replace the
functionality of an impaired native valve, leading to better
regulation of blood flow and improved cardiovascular function.
However, many existing prosthetic heart valves require implantation
via an open heart procedure, which is highly-invasive and may cause
life-threatening complications. Other prosthetic valves may be
collapsed within a prosthetic valve delivery system and advanced
into the heart, at which point the prosthetic valve may be removed
from the delivery system and expanded at the native valve site.
However, many of these prosthetic valves are large in size and
therefore difficult to deliver into the heart without causing
damage to healthy tissue along the implantation route. In addition,
once these prosthetic valves are situated within the heart, they
may be difficult to securely implant at the native valve site due
to their complex structure and the limited maneuverability of
existing prosthetic valve delivery systems within the heart.
Moreover, many prosthetic valves are so large that they may
protrude several centimeters into surrounding heart chambers once
they are implanted, impairing cardiac filling and causing injury to
the anatomy within the heart.
[0005] Thus, there remains a need for prosthetic heart valves that
are smaller in size but that are still configured to assist or
replace the functionality of a diseased or damaged native heart
valve. In addition, there remains a need for prosthetic heart
valves that are more easily maneuvered into the heart and securely
implanted at the site of a native heart valve. Moreover, there
remains a need for improved prosthetic heart valve delivery systems
that are configured to securely implant a prosthetic heart valve at
an implantation site. The present disclosure provides prosthetic
heart valves with a reduced axial length such that the prosthetic
heart valves may be more easily delivered into the heart and may
exhibit less protrusion into the chambers of the heart. The present
disclosure also provides improved prosthetic heart valve delivery
systems and methods of implanting prosthetic heart valves, such
that prosthetic heart valves may be securely anchored at the
implantation site.
SUMMARY
[0006] The present disclosure discloses prosthetic valves for
implantation within a native mitral valve and methods for
implanting prosthetic valves within a native mitral valve.
Particular examples of the disclosure may pertain to a prosthetic
valve having overlapping atrial tissue anchors and ventricular
tissue anchors.
[0007] According to an exemplary embodiment of the present
disclosure, a prosthetic valve for implantation within a native
heart valve is provided. The prosthetic valve includes an annular
outer frame having a plurality of ventricular anchoring legs
configured to extend therefrom. The prosthetic valve additionally
includes an inner frame positioned at least partially within the
annular outer frame. The inner frame includes a plurality of atrial
anchoring arms configured to extend therefrom. A portion of each of
the plurality of ventricular anchoring legs is configured to
overlap with a portion of each of the plurality of atrial anchoring
arms in a common lateral plane.
[0008] The common lateral plane is perpendicular to a longitudinal
axis of the prosthetic valve. The atrial anchoring arms and
ventricular anchoring legs are configured to extend radially
outward from the inner frame and from the annular outer frame,
respectively. The prosthetic valve has an axial length of two
centimeters or less. The prosthetic valve is configured to protrude
a distance of 15 millimeters or less into a ventricle of the heart
when the prosthetic valve is implanted within the native heart
valve. An entire length of at least one ventricular anchoring leg
is configured to extend in a non-ventricular direction. At least
one atrial anchoring arm includes a first portion configured to
extend in an atrial direction and a second portion configured to
extend in a ventricular direction. A diameter defined by terminal
ends of the atrial anchoring arms is at least twice as large as a
diameter of an inlet opening of the inner frame. An axial length of
the prosthetic valve is at least as large as a radius of an inlet
opening of the inner frame. An axial length of the inner frame is
at least as large as a radius of an inlet opening of the inner
frame. The prosthetic valve includes a plurality of leaflets
secured within the inner frame. At least one of the leaflets has a
radius of between thirteen and fifteen millimeters. An axial length
of the prosthetic valve is at least as large as the radius of at
least one of the leaflets secured within the inner frame. An axial
length of the inner frame is at least as large as a radius of at
least one of the leaflets secured within the inner frame. A
diameter defined by terminal ends of the atrial anchoring arms is
at least 1.2 times larger than a diameter defined by terminal ends
of the ventricular anchoring legs. A diameter defined by terminal
ends of the atrial anchoring arms is at least 2.5 times larger than
an axial length of the prosthetic valve. The diameter defined by
the terminal ends of the atrial anchoring arms is between 2.6 and
2.9 times larger than the axial length of the prosthetic valve. The
inner frame has a greater axial length than the annular outer
frame. A portion of at least one ventricular anchoring leg is
configured to be substantially aligned in a common lateral plane
with an atrial end of the inner frame. At least one ventricular
anchoring leg is configured to extend from a single portion of the
annular outer frame. None of the ventricular anchoring legs share a
common connection point to the annular outer frame. At least one
atrial anchoring arm is configured to extend from a single portion
of the inner frame. None of the atrial anchoring arms share a
common connection point to the inner frame.
[0009] Additional features and advantages of the disclosed
embodiments will be set forth in part in the description that
follows, and in part will be obvious from the description, or may
be learned by practice of the disclosed embodiments. The features
and advantages of the disclosed embodiments will be realized and
attained by the elements and combinations particularly pointed out
in the appended claims.
[0010] It is to be understood that both the foregoing general
description and the following detailed description are examples and
explanatory only and are not restrictive of the disclosed
embodiments as claimed.
[0011] The accompanying drawings constitute a part of this
specification. The drawings illustrate several embodiments of the
present disclosure and, together with the description, serve to
explain the principles of the disclosed embodiments as set forth in
the accompanying claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 A illustrates a front elevation view of an exemplary
frame for a prosthetic valve, consistent with various embodiments
of the present disclosure.
[0013] FIG. 1B illustrates a perspective view of the exemplary
frame of FIG. 1A, consistent with various embodiments of the
present disclosure.
[0014] FIG. 2A illustrates a front elevation view of another
exemplary frame for a prosthetic valve, consistent with various
embodiments of the present disclosure.
[0015] FIG. 2B illustrates a top plan view of the exemplary frame
of FIG. 2A, consistent with various embodiments of the present
disclosure.
[0016] FIG. 2C illustrates an enlarged view of an atrial anchoring
arm and a ventricular anchoring leg of the exemplary frame of FIG.
2A, consistent with various embodiments of the present
disclosure.
[0017] FIG. 2D illustrates another front elevation view of the
exemplary frame of FIG. 2A, consistent with various embodiments of
the present disclosure.
[0018] FIG. 2E illustrates another top plan view of the exemplary
frame of FIG. 2A, consistent with various embodiments of the
present disclosure.
[0019] FIG. 3A illustrates a front elevation view of an inner frame
of the exemplary frame of FIG. 2A, consistent with various
embodiments of the present disclosure.
[0020] FIG. 3B illustrates an enlarged view of an atrial anchoring
arm of the exemplary inner frame of FIG. 3A, consistent with
various embodiments of the present disclosure.
[0021] FIG. 3C illustrates a front elevation view of an outer frame
of the exemplary frame of FIG. 2A, consistent with various
embodiments of the present disclosure.
[0022] FIG. 3D illustrates an enlarged view of a ventricular
anchoring leg of the exemplary outer frame of FIG. 3C, consistent
with various embodiments of the present disclosure.
[0023] FIG. 4A illustrates a cross-sectional view of the exemplary
frame of FIG. 2A, consistent with various embodiments of the
present disclosure.
[0024] FIG. 4B illustrates an enlarged view of a volume between an
atrial anchoring arm and a ventricular anchoring leg of the
exemplary frame of FIG. 4A, consistent with various embodiments of
the present disclosure.
[0025] FIGS. 5A-5E illustrate structural changes in the exemplary
frame of FIG. 2A during transitioning of the frame between a
radially-contracted configuration and a radially-expanded
configuration, consistent with various embodiments of the present
disclosure.
[0026] FIG. 6A illustrates a front elevation view of an exemplary
prosthetic valve, consistent with various embodiments of the
present disclosure.
[0027] FIG. 6B illustrates a cross-sectional view of the exemplary
prosthetic valve of FIG. 6A without leaflets, consistent with
various embodiments of the present disclosure.
[0028] FIG. 6C illustrates a cross-sectional view of the exemplary
prosthetic valve of FIG. 6A with leaflets, consistent with various
embodiments of the present disclosure.
[0029] FIG. 6D illustrates a top plan view of the exemplary
prosthetic valve of FIG. 6A with uninflated leaflets, consistent
with various embodiments of the present disclosure.
[0030] FIG. 6E illustrates a top plan view of the exemplary
prosthetic valve of FIG. 6A with inflated leaflets, consistent with
various embodiments of the present disclosure.
[0031] FIG. 7A illustrates an exemplary prosthetic valve delivery
system, consistent with various embodiments of the present
disclosure.
[0032] FIG. 7B illustrates an enlarged view of a delivery capsule
of the exemplary prosthetic valve delivery system of FIG. 7A,
consistent with various embodiments of the present disclosure.
[0033] FIG. 7C illustrates an exemplary configuration of a
telescoping catheter assembly and the delivery capsule of the
exemplary prosthetic valve delivery system of FIG. 7A, consistent
with various embodiments of the present disclosure.
[0034] FIG. 7D illustrates another exemplary configuration of the
telescoping catheter assembly and delivery capsule of FIG. 7C,
consistent with various embodiments of the present disclosure.
[0035] FIG. 8A illustrates another enlarged view of the exemplary
delivery capsule of the prosthetic valve delivery system of FIG. 7A
in a closed configuration, consistent with various embodiments of
the present disclosure.
[0036] FIG. 8B illustrates the exemplary delivery capsule of FIG.
8A in an open configuration, consistent with various embodiments of
the present disclosure.
[0037] FIG. 8C illustrates an interior view of the exemplary
delivery capsule of FIG. 8A in the closed configuration, consistent
with various embodiments of the present disclosure.
[0038] FIG. 9 illustrates advancement of the exemplary prosthetic
valve delivery system of FIG. 7A into the left atrium, consistent
with various embodiments of the present disclosure.
[0039] FIGS. 10A-10H depict implantation of the prosthetic valve of
FIGS. 6A-6E within a native mitral valve by the exemplary
prosthetic valve delivery system of FIG. 7A, consistent with
various embodiments of the present disclosure.
DETAILED DESCRIPTION
[0040] Exemplary embodiments are described with reference to the
accompanying drawings. In the figures, which are not necessarily
drawn to scale, the left-most digit(s) of a reference number
identifies the figure in which the reference number first appears.
Wherever convenient, the same reference numbers are used throughout
the drawings to refer to the same or like parts. While examples and
features of disclosed principles are described herein,
modifications, adaptations, and other implementations are possible
without departing from the spirit and scope of the disclosed
embodiments. Also, the words "comprising," "having," "containing,"
and "including," and other similar forms are intended to be
equivalent in meaning and be open ended in that an item or items
following any one of these words is not meant to be an exhaustive
listing of such item or items, or meant to be limited to only the
listed item or items. It should also be noted that as used in the
present disclosure and in the appended claims, the singular forms
"a," "an," and "the" include plural references unless the context
clearly dictates otherwise.
[0041] In some embodiments of the present disclosure, an "atrial
direction" may refer to a direction extending towards an atrium of
the heart. For example, from a location within the left ventricle
or the mitral valve, an atrial direction may refer to a direction
extending towards the left atrium. Additionally, from a location
within an atrium (e.g., the left atrium), an atrial direction may
refer to a direction extending away from an adjacent
atrioventricular valve (e.g., the mitral valve) and further into
the atrium. For example, in FIGS. 10G and 10H, an atrial direction
may refer to a direction extending upwards from prosthetic valve
6000 towards atrium 9010. In some exemplary embodiments, an atrial
direction need not necessarily be parallel to a longitudinal axis
of a prosthetic valve (e.g., longitudinal axis 2800 illustrated in
FIG. 2A), so long as the direction is angled towards an atrium. The
atrial direction may be parallel to a longitudinal axis of a
prosthetic valve in some cases. In some embodiments, a
"non-ventricular direction" may refer to a direction that does not
extend towards a ventricle of the heart. A "non-ventricular
direction" may extend in an atrial direction, or it may extend
laterally in a direction perpendicular to a ventricular
direction.
[0042] In some exemplary embodiments of the present disclosure, a
"ventricular direction" may refer to a direction extending towards
a ventricle of the heart. From a location within the left atrium or
the mitral valve, a ventricular direction may refer to a direction
extending towards the left ventricle. Additionally, from a location
within a ventricle (e.g., the left ventricle), a ventricular
direction may refer to a direction extending away from an adjacent
atrioventricular valve (e.g., the mitral valve) and further into
the ventricle. For example, in FIGS. 10G and 10H, a ventricular
direction may refer to a direction extending downwards from
prosthetic valve 6000 towards ventricle 9020. In some exemplary
embodiments, a ventricular direction need not necessarily be
parallel to a longitudinal axis of a prosthetic valve (e.g.,
longitudinal axis 2800 illustrated in FIG. 2A), so long as the
direction is angled towards a ventricle. The ventricular direction
may be parallel to a longitudinal axis of a prosthetic valve in
some cases. In some embodiments, a "non-atrial direction" may refer
to a direction that does not extend towards an atrium of the heart.
A non-atrial direction may extend in a ventricular direction, or it
may extend laterally in a direction perpendicular to an atrial
direction.
[0043] Exemplary embodiments generally relate to prosthetic valves
for implantation within a native valve and methods for implanting
prosthetic valves within a native valve. In addition, exemplary
embodiments generally relate to systems and methods for
implantation of prosthetic valves by prosthetic valve delivery
systems. While the present disclosure provides examples relating to
prosthetic heart valves, and in particular prosthetic mitral
valves, as well as delivery systems for prosthetic heart valves, it
should be noted that aspects of the disclosure in their broadest
sense are not limited to a prosthetic heart valve. Rather, the
foregoing principles may be applied to other prosthetic valves as
well. In various embodiments in accordance with the present
disclosure, the term prosthetic valve refers generally to an
implantable valve configured to restore and/or replace the
functionality of a native valve, such as a diseased or otherwise
impaired native heart valve.
[0044] An exemplary prosthetic valve may include a prosthetic valve
configured to render a native valve structure non-functional, and
may thus replace the function of the native valve. For example, an
exemplary prosthetic valve may have a size and shape similar to the
valve being replaced and may include a number of leaflet-like
structures to regulate fluid flow and prevent backflow of blood
through the valve. Additionally, or alternatively, an exemplary
prosthetic valve may also include a prosthetic valve configured to
leave the native valve structure intact and functional. An
exemplary prosthetic valve may include a mitral valve, tricuspid
valve, aortic valve, or pulmonary valve, as well as a valve outside
of the heart, such as a venous valve, lymph node valve, ileocecal
valve, or any other structure configured to control and/or regulate
fluid flow in the body. An exemplary prosthetic valve may
additionally or alternatively be configured to replace a failed
bioprosthesis, such as a failed heart valve prosthesis.
[0045] FIG. 1 A illustrates a front elevation view of an exemplary
frame 1000 for a prosthetic valve. FIG. 1B illustrates a
perspective view of frame 1000. Frame 1000 may be constructed of a
shape memory material such as nickel titanium alloy (Nitinol) and
may be configured to support other components of the prosthetic
valve, such as prosthetic leaflets and protective cover layers.
Frame 1000 may include an annular outer frame 1200 and an inner
frame 1400 situated at least partially within the outer frame 1200.
Annular outer frame 1200 and inner frame 1400 may be secured
together by pins, screws, welding, soldering, adhesive, magnets,
and/or any other suitable mechanism. For example, FIGS. 1 A and 1B
depict annular outer frame 1200 and inner frame 1400 connected by a
plurality of connector pins 1040.
[0046] Annular outer frame 1200 may include an outer frame tubular
portion 1220, which may be formed of a plurality of struts
intersecting at junctions to form a wire mesh, stent-like, or
cage-like structure of the outer frame tubular portion 1220.
Annular outer frame 1200 may also include at least one ventricular
anchoring leg 1240, which may be configured to extend radially
outward from the outer frame tubular portion and which may contact,
or otherwise engage, tissue within or near the native valve to
anchor the prosthetic valve within the native valve. In some
embodiments, exemplary valve frame 1000 may include twelve
ventricular anchoring legs 1240, which may be configured to engage
ventricular tissue of a native atrioventricular valve.
[0047] Inner frame 1400 may include an inner frame tubular portion
1420, which may be formed of a plurality of struts intersecting at
junctions to form a wire mesh, stent-like, or cage-like structure
of the inner frame tubular portion 1420. Inner frame 1400 may also
include at least one atrial anchoring arm 1440, which may be
configured to extend radially outward from the inner frame tubular
portion and which may contact, or otherwise engage, tissue within
or near the native valve to anchor the prosthetic valve within the
native valve. In some embodiments, exemplary valve frame 1000 may
include twelve atrial anchoring arms 1440, which may be configured
to engage atrial tissue of a native atrioventricular valve.
[0048] Outer frame tubular portion 1220 and inner frame tubular
portion 1420 may together form an annular valve body 1020 of the
prosthetic valve, which may have at least one opening and from
which the ventricular anchoring legs 1240 and atrial anchoring arms
1440 may extend. Annular valve body 1020 may include an axial lumen
1022 extending through the annular valve body 1020 along a
longitudinal axis 1800 of the prosthetic valve. In some
embodiments, annular valve body 1020 may be configured to receive a
flow control device, such as one or more prosthetic leaflets,
within axial lumen 1022. Optionally, annular valve body 1020 may
include one or more atrial end delivery posts 1027 along an atrial
end (i.e., top end) of the annular valve body and/or one or more
ventricular end delivery posts 1028 along a ventricular end (i.e.,
bottom end) of the annular valve body. Delivery posts 1027 and 1028
may be configured to removably engage a delivery device of the
prosthetic valve, for example, to assist with placement of frame
1000 within or near a native valve.
[0049] FIG. 2A illustrates a front view of another exemplary frame
2000 for a prosthetic valve. FIG. 2B illustrates a top plan view of
the frame 2000. Frame 2000 may include an annular outer frame 2200
and an inner frame 2400 situated at least partially within the
annular outer frame 2200. Annular outer frame 2200 and inner frame
2400 may be secured together by pins, screws, welding, soldering,
adhesive, magnets, and/or any other suitable mechanism. For
example, FIGS. 2A and 2B depict annular outer frame 2200 and inner
frame 2400 connected by a plurality of connector pins 2040.
[0050] Annular outer frame 2200 may include an outer frame tubular
portion 3605, which may be formed of a plurality of struts
intersecting at junctions to form a wire mesh, stent-like, or
cage-like structure of the outer frame tubular portion 3605. For
example, as illustrated in FIG. 2A, annular outer frame 2200 may
include outer frame atrial circumferential struts 3608a, outer
frame leg base struts 3608b, and outer frame ventricular
circumferential struts 3608c intersecting at atrial end outer frame
junctions 3602, leg attachment junctions 3802, outer frame
junctions 3804, and ventricular end outer frame junctions 3604 to
form outer frame tubular portion 3605. Annular outer frame 2200 may
also include at least one ventricular anchoring leg 2240, which may
extend from leg attachment junction 3802 of the outer frame tubular
portion 3605 and which may be configured to engage ventricular
tissue of a native valve to anchor the prosthetic valve in the
native valve. The at least one ventricular anchoring leg 2240 may
include a proximal leg end 3622, which may be the end of the leg
connected to the outer frame tubular portion, and a distal leg end
2244, which may be situated radially outward from the outer frame
tubular portion. As shown in FIG. 2B, the at least one ventricular
anchoring leg 2240 may include at least one opening 2242.
[0051] Inner frame 2400 may include an inner frame tubular portion
3005, which may be formed of a plurality of struts intersecting at
junctions to form a wire mesh, stent-like, or cage-like structure
of the inner frame tubular portion 3005. For example, as
illustrated in FIG. 2A, inner frame 2400 may include inner frame
atrial struts 3008a, inner frame intermediate struts 3008b, and
inner frame ventricular struts 3008c intersecting at atrial end
inner frame junctions 3002, arm attachment junctions 3202, inner
frame strut junctions 3204, and ventricular end inner frame
junctions 3004 to form inner frame tubular portion 3005. Inner
frame 2400 may also include at least one atrial anchoring arm 2440,
which may extend from arm attachment junction 3202 of the inner
frame tubular portion 3005 and which may be configured to engage
atrial tissue of a native valve to anchor the prosthetic valve in
the native valve. The at least one atrial anchoring arm 2440 may
include a proximal arm end 3020, which may be the end of the arm
connected to the inner frame tubular portion, and a distal arm end
2444, which may be situated radially outward from the inner frame
tubular portion. As shown in FIG. 2B, the at least one atrial
anchoring arm 2440 may include a proximal arm opening 2441 and a
distal arm opening 2442.
[0052] Outer frame tubular portion 3605 and inner frame tubular
portion 3005 may together form an annular valve body 2020 of the
prosthetic valve, which may have at least one opening and from
which the ventricular anchoring legs 2240 and atrial anchoring arms
2440 may extend. Annular valve body 2020 may include an axial lumen
2022 extending through the annular valve body 2020 along a
longitudinal axis 2800 of the prosthetic valve. Annular valve body
2020 may have an atrial end 2024, a ventricular end 2025 opposite
the atrial end, and an intermediate portion 2026 extending between
the atrial and ventricular ends. In some embodiments, the atrial
end may refer to the portion of the annular valve body configured
to be situated at a location within the atrium that is furthest
from an adjacent ventricle, when the prosthetic valve is implanted
in a native valve. Similarly, the ventricular end may refer to the
portion of the annular valve body configured to be situated at a
location within the ventricle that is furthest from an adjacent
atrium, when the prosthetic valve is implanted in a native valve.
The intermediate portion 2026 may extend between the atrial end
2024 and ventricular end 2025. In some embodiments, annular valve
body 2020 may include one or more ventricular end delivery posts
1028 along the ventricular end 2025 of the annular valve body.
Axial lumen 2022 may include an inlet opening 2032 at the atrial
end of the annular valve body, as well as an outlet opening 2036 at
the ventricular end of the annular valve body.
[0053] FIG. 2C illustrates an enlarged view of an atrial anchoring
arm 2440 and a ventricular anchoring leg 2240 of frame 2000.
Ventricular anchoring leg 2240 may include an inner,
atrially-facing leg surface 2248 and an outer, ventricularly-facing
leg surface 2249. Atrial anchoring arm 2440 may include an
atrially-facing arm surface 2448 and a ventricularly-facing arm
surface 2449. In some embodiments, atrial anchoring arm 2440 may
include an arm portion 2446 configured to be arranged in a common
lateral plane with leg portion 2246 of the ventricular anchoring
leg 2240. That is, leg portion 2246 and arm portion 2446 may be
positioned at the same axial position along longitudinal axis
2800.
[0054] FIG. 2D illustrates another front elevation view of frame
2000. The exemplary prosthetic valve, as well as frame 2000, may
have an axial height 2560, which may extend between terminal arm
ends 2444 and ventricular end 2025 of the annular valve body. Inner
frame tubular portion 3005 may have an axial height 2530, which may
extend between atrial end inner frame junctions 3002 and
ventricular end inner frame junctions 3004. Annular outer frame
2200 may have an axial height 2550, which may extend between
terminal leg ends 2244 and ventricular end 2025 of the annular
valve body. Outer frame tubular portion 3605 may have an axial
height 2570, which may extend between atrial end outer frame
junctions 3602 and ventricular end outer frame junctions 3604. In
some embodiments, frame 2000 may have a ventricular device
protrusion distance 2540, which may represent the distance over
which the prosthetic valve protrudes into a left ventricle when the
prosthetic valve is implanted in a native mitral valve. Annular
valve body 2020 may include a valve inlet radius 2520, which may be
the radius of atrial inlet opening 2032.
[0055] FIG. 2E illustrates another top plan view of frame 2000. The
atrial anchoring arms 2440 may have a length 2580, and the
ventricular anchoring legs 2240 may have a length 2590. The
terminal arm ends 2444 may define an atrial anchoring arm
circumference 2640. The terminal leg ends 2244 may define a
ventricular anchoring leg circumference 2620, which may be
concentric with atrial anchoring arm circumference 2640. Inflexible
portions 3402 of the atrial anchoring arms (illustrated in FIG. 3B)
may have a length 2581. Serpentine structures 3406 of the atrial
anchoring arms (illustrated in FIG. 3B) may have a length 2582.
[0056] FIG. 3A illustrates a front elevation view of inner frame
2400. The atrial end inner frame junctions 3002 and ventricular end
inner frame junctions 3004 may form the atrial end and ventricular
end, respectively, of inner frame 2400. Inner frame intermediate
portion 3006 may extend between atrial end inner frame junctions
3002 and ventricular end inner frame junctions 3004. Inner frame
tubular portion 3005 may have a radially inner surface 3018 and a
radially outer surface 3016. Inner frame atrial struts 3008a and
inner frame intermediate struts 3008b may intersect at atrial end
inner frame junctions 3002, arm attachment junctions 3202, and
strut junctions 3204 to form a first, atrial row of closed cells
3012. Inner frame intermediate struts 3008b and inner frame
ventricular struts 3008c may intersect at arm attachment junctions
3202, strut junctions 3204, and ventricular end inner frame
junctions 3004 to form a second, ventricular row of closed cells
3014. At least one inner frame atrial strut 3008a may have a
cross-sectional area 3010. At least one atrial anchoring arm 2440
may have a cross-sectional area 3022.
[0057] FIG. 3B illustrates an enlarged view of an atrial anchoring
arm 2440 of inner frame 2400. Atrial anchoring arm 2440 may include
a proximal arm portion 3502 configured to extend in an atrial
direction, intermediate arm portion 3504 configured to extend in a
ventricular direction, and distal arm portion 3506 configured to
extend in an atrial direction. Arm transition portion 3508 may
represent the transition between intermediate arm portion 3504 and
distal arm portion 3506. Atrial anchoring arm 2440 may also include
an inflexible portion 3402 extending to proximal arm end 3020, as
well as a serpentine structure 3406, which may be situated radially
external to the inflexible portion 3402. Inflexible portion 3402
may have a proximal end 3402p, a distal end 3402d, and a
cross-sectional area 3402c. Serpentine structure 3406 may have a
cross-sectional area 3406c. In some embodiments, atrial anchoring
arm 2440 may include a terminal arm region 3408 situated radially
external to serpentine structure 3406. Distal arm opening 2442 may
be situated within terminal arm region 3408.
[0058] FIG. 3C illustrates a front elevation view of outer frame
2200. The atrial end outer frame junctions 3602 and ventricular end
outer frame junctions 3604 may form the atrial end and ventricular
end, respectively, of annular outer frame 2200. Outer frame
intermediate portion 3606 may extend between atrial end outer frame
junctions 3602 and ventricular end outer frame junctions 3604.
Outer frame tubular portion 3605 may have a radially outer surface
3618 and a radially inner surface 3620. The outer frame atrial
circumferential struts 3608a, outer frame leg base struts 3608b,
and outer frame ventricular circumferential struts 3608c may
intersect at the atrial end outer frame junctions 3602, leg
attachment junctions 3802, outer frame junctions 3804, and
ventricular end outer frame junctions 3604 to form closed cells
3616. At least one outer frame atrial circumferential strut 3608a
may have a cross-sectional area 3610 and a width 3612. At least one
outer frame leg base strut 3608b may have a cross-sectional area
3614. At least one ventricular anchoring leg may have a
cross-sectional area 3624 and a radially outer surface width
3626.
[0059] FIG. 3D illustrates an enlarged view of a portion of a
ventricular anchoring leg 2240 of annular outer frame 2200.
Ventricular anchoring leg 2240 may include a first, proximal curved
portion 3807 and a second, distal curved portion 3808. In some
embodiments, proximal curved portion 3807 may face radially
outward. Additionally, or alternatively, distal curved portion 3808
may face radially inwards.
[0060] FIG. 4A illustrates a cross-sectional view of frame 2000,
and FIG. 4B illustrates an enlarged view of a portion of FIG. 4A
depicting a volume 4000 formed between the atrial anchoring arms
2440 and ventricular anchoring legs 2240. FIG. 4B also depicts an
outer surface 4010 and inner surface 4020 of annular valve body
2020. In some embodiments, volume 4000 may be bounded by the
ventricularly-facing surfaces 2449 of atrial anchoring arms 2440,
by the inner, atrially-facing surfaces 2248 of ventricular
anchoring legs 2240, and by the outer surface 4010 of the annular
valve body 2020.
[0061] FIG. 5A illustrates a configuration of the exemplary
prosthetic valve in which annular valve body 2020, atrial anchoring
arms 2440, and ventricular anchoring legs 2240 are arranged in a
radially-contracted configuration. In some embodiments, the
configuration illustrated in FIG. 5A may constitute a
radially-contracted configuration of the prosthetic valve.
[0062] FIG. 5B illustrates a configuration of the exemplary
prosthetic valve in which annular valve body 2020 and atrial
anchoring arms 2440 are arranged in a radially-contracted
configuration. In the configuration of FIG. 5B, the ventricular
anchoring legs 2240 may deflect radially outward away from annular
valve body 2020, into a radially-expanded configuration of the
ventricular anchoring legs 2240.
[0063] FIG. 5C illustrates a configuration of the exemplary
prosthetic valve in which annular valve body 2020 and ventricular
anchoring legs 2240 are arranged in a radially-contracted
configuration. In the configuration of FIG. 5C, the atrial
anchoring arms 2440 may deflect radially outward away from annular
valve body 2020, into a radially-expanded configuration of the
atrial anchoring arms 2440.
[0064] FIG. 5D illustrates a configuration of the exemplary
prosthetic valve in which the atrial anchoring arms 2440 and
ventricular anchoring legs 2240 may deflect radially outward away
from annular valve body 2020 into their respective
radially-expanded configurations, while annular valve body 2020
remains in a radially-contracted configuration. In the
configuration of FIG. 5D, an axial distance 5004 may be formed
between the atrial anchoring arms 2440 and the terminal ends 2244
of the ventricular anchoring legs 2240.
[0065] FIG. 5E illustrates a configuration of the exemplary
prosthetic valve in which annular valve body 2020, atrial anchoring
arms 2440, and ventricular anchoring legs 2240 are arranged in a
radially-expanded configuration. In some embodiments, the
configuration illustrated in FIG. 5E may constitute a
radially-expanded configuration of the prosthetic valve.
[0066] FIG. 6A illustrates a front elevation view of prosthetic
valve 6000. In some embodiments, prosthetic valve 6000 may be
assembled upon frame 2000. Prosthetic valve 6000 may be configured
for implantation within or near a native valve structure and may be
configured to restore and/or replace the functionality of a native
valve, such as a diseased or otherwise impaired native valve.
Prosthetic valve 6000 may include valve frame 2000, including
annular valve body 2020, the atrial anchoring arms 2440, and the
ventricular anchoring legs 2240. Prosthetic valve 6000 may also
include a skirt layer 6100 configured around an external surface of
a portion of the annular valve body. Prosthetic valve 6000 may
additionally include a first cuff sheet 6210, which may be
connected to skirt layer 6100 via stitching 6104, as well as a
second cuff sheet 6220, which may be connected to first cuff sheet
6210 via stitching 6420. In some embodiments, the first cuff sheet
6210 and second cuff sheet 6220 by extend around the terminal ends
2444 of the atrial anchoring arms 2440. Skirt layer 6100, first
cuff sheet 6210, and second cuff sheet 6220 may be constructed of
fluid-impermeable material and may accordingly be configured to
prevent passage of blood or other fluids through portions of the
prosthetic valve 6000 outside of the axial lumen 2022.
[0067] In some embodiments, prosthetic valve 6000 may additionally
include a protective sleeve 6102 wrapped around the rim 6800 of the
ventricular outlet opening of annular valve body 2020; protective
sleeve 6102 may be secured to annular valve body 2020 by stitching
6108. Additionally, or alternatively, prosthetic valve 6000 may
include at least one liner 6310 extending around an external
surface of the ventricular anchoring legs 2240, with at least one
protective layer 6330 positioned around the distal leg ends 2244
and at least one protective covering 6320 wrapped around the
proximal leg ends 3622. In some embodiments, the at least one
protective covering 6320 may be secured to the skirt layer 6100 via
stitching 6322.
[0068] FIG. 6B illustrates a cross-sectional view of prosthetic
valve 6000, without prosthetic leaflets situated within the axial
lumen 2022. As illustrated in FIG. 6B, prosthetic valve 6000 may
additionally include a liner 6400 covering at least a portion of
the inner surface 4020 of the annular valve body 2020. Liner 6400
may be secured to the annular valve body 2020 via stitching 6430
and to the second cuff sheet 6220 via stitching 6410. First cuff
sheet 6210, second cuff sheet 6220, and inner liner 6400 may
together form an inflatable cuff 6200 having an interior volume
6500. In some embodiments, inflatable cuff 6200 may be secured to
atrial anchoring arm 2440 via connector 6440. Blood may enter the
cuff 6200 through openings 6230, causing the cuff 6200 to inflate
radially outwards and axially in an atrial direction. In some
embodiments, cuff 6200 may inflate radially outwards and press
against tissue of the native valve. This engagement between the
cuff and tissue of the native valve may form a barrier to flow of
blood and other fluids around the outer circumference of the
prosthetic valve 6000.
[0069] FIG. 6C illustrates a cross-sectional view of prosthetic
valve 6000 with prosthetic leaflets 6602 and 6604 situated within
the axial lumen 2022. In some embodiments, prosthetic valve 6000
may also include a third prosthetic leaflet 6606, which may not be
visible in the view of FIG. 6C. The leaflets 6602, 6604, and 6606
may be secured to inner liner 6400 via stitching 6608 and may
include a connector 6610 wrapping around the ventricular end
delivery posts 2028 to secure the leaflets 6602, 6604, and 6606 to
the valve frame 2000.
[0070] FIG. 6D illustrates a top plan view of prosthetic valve
6000, with leaflets 6602, 6604, and 6606 arranged in an open,
uninflated configuration. In the open configuration, a space may be
formed in the middle of the leaflets, permitting fluid to pass
through the axial lumen 2022 of the prosthetic valve 6000. FIG. 6E
illustrates a top plan view of prosthetic valve 6000, with leaflets
6602, 6604, and 6606 arranged in a closed, coapted configuration.
In the closed configuration, the leaflets may press together such
that the opening between them is closed. For example, the point of
contact 6007 between two adjacent leaflets may extend to the center
of the axial lumen; as a result, the leaflets may block fluid
passage through the axial lumen 2022 of the prosthetic valve
6000.
[0071] FIG. 7A illustrates a prosthetic valve delivery system 7000.
Delivery system 7000 may be configured to deliver an implant
prosthetic valve 6000 within a native valve, such as a native
mitral valve. Prosthetic valve delivery system 7000 may include a
control handle assembly 7100, a telescoping catheter assembly 7200,
a delivery capsule 7300 configured to retain a prosthetic valve
(e.g. valve 6000), and, optionally, a stand 7400.
[0072] Control handle assembly 7100 may include an outer sheath
control handle 7120 having a steering knob 7122 configured to steer
an outer sheath 7210 of the telescoping catheter assembly 7200.
Control handle assembly 7100 may also include a guide catheter
control handle 7140 having a steering knob 7142 configured to steer
a guide catheter 7220 of the telescoping catheter assembly
7200.
[0073] Control handle assembly 7100 may also include an implant
catheter control handle 7160 having a steering knob 7168 configured
to steer an implant catheter 8100 of the telescoping catheter
assembly 7200. Implant catheter control handle 7160 may also
include a proximal capsule portion slider 7162, a distal capsule
portion knob 7170, and a distal capsule portion knob lock 7172
configured to control release of the prosthetic valve 6000 from
within delivery capsule 7300. Implant catheter control handle 7160
may also include a slide lock 7166 configured to lock the implant
catheter control handle 7160 at a position within track 7420 of
stand 7400.
[0074] Control handle assembly 7100 may also include a cradle 7180,
which may be secured to stand 7400 via a locking mechanism that can
be released by actuated of release button 7184. Cradle 7180 may
include a rotation knob 7182 configured to control rotation of the
outer sheath 7210 and guide catheter 7220. Cradle 7180 may also
include a rotation knob 7186 configured to control rotation of the
implant catheter 8100. Cradle 7180 may also include a knob 7188
configured to control relative axial movement between outer sheath
control handle 7120 (which may be secured to outer sheath 7210) and
guide catheter control handle 7140 (which may be secured to guide
catheter 7220).
[0075] FIG. 7B illustrates an enlarged view of delivery capsule
7300 of prosthetic valve delivery system 7000. Delivery capsule
7300 may include a proximal capsule portion 7320 and a distal
capsule portion 7340 with a nose cone 7360 secured to the distal
capsule portion 7340. A nose cone distal tip 7365 may form the
distal end of the delivery capsule 7300. The telescoping catheter
assembly 7200 may include a capsule shaft 7230 secured to, and
configured to control movement of, the proximal capsule portion
7320 (e.g., due to connection 8400 between the capsule shaft 7230
and proximal capsule portion 7320, as illustrated in FIG. 8C).
Implant catheter 8100 may extend within proximal capsule portion
7320 and may have a valve anchor disc 8200 connected to the distal
end of the implant catheter 8100. A torque shaft 8300 may extend
from the implant catheter 8100 and may be connected to distal
capsule portion 7340; accordingly, torque shaft 8300 may be
configured to control axial movement of the distal capsule portion
7340 relative to the implant catheter 8100 and valve anchor disc
8200. The proximal capsule portion 7320 and a distal capsule
portion 7340 may be configured to retain prosthetic valve 6000,
with the prosthetic valve 6000 secured against axial movement by
valve anchor disc 8200. Control handle assembly 7100 may be
configured to control movement of the proximal capsule portion 7320
and a distal capsule portion 7340, and thus may also control
release of the prosthetic valve 6000 from within the delivery
capsule 7300.
[0076] FIGS. 7C and 7D illustrate exemplary configurations of the
telescoping catheter assembly 7200. Outer sheath 7210 and guide
catheter 7220 may include respective bending portions 7215 and
7225, at which the outer sheath 7210 and guide catheter 7220 may be
configured to bend within their respective steering planes 7212 and
7222. In some embodiments, bending of the outer sheath 7210 within
the first steering plane 7212 may be controlled by the outer sheath
steering knob 7122 of the control handle assembly 7100.
Additionally, or alternatively, bending of the guide catheter 7220
within the second steering plane 7222 may be controlled by the
guide catheter steering knob 7142 of the control handle assembly
7100. In some embodiments, under control of the control handle
assembly 7100, the outer sheath 7210, guide catheter 7220, and
implant catheter 8100 may be steered so as to correctly position
the delivery capsule 7300 within a native valve for implantation of
the prosthetic valve.
[0077] FIG. 8A illustrates an enlarged view of delivery capsule
7300 in a closed configuration, while FIG. 8B illustrates an
enlarged view of delivery capsule 7300 in an open configuration. In
the closed configuration of FIG. 8A, the distal capsule portion
7340 and proximal capsule portion 7320 may be brought together to
form an enclosed compartment in which prosthetic valve 6000 may be
retained. In the open configuration of FIG. 8B, the distal capsule
portion 7340 and proximal capsule portion 7320 may be drawn apart.
In some embodiments, the delivery capsule 7300 may be configured
such that the distal capsule portion 7340 and proximal capsule
portion 7320 are moved apart from each other, the prosthetic valve
6000 may be sequentially deployed from within the delivery capsule
and implanted within a native valve.
[0078] FIG. 8C illustrates an interior view of delivery capsule
7300 with prosthetic valve 6000 retained within the delivery
capsule. Although only the valve frame 2000 of the prosthetic valve
6000 is illustrated in FIG. 8C, one of ordinary skill will
understand that the entire prosthetic valve 6000 depicted in FIGS.
6A-6E may be retained within delivery capsule 7300 in the
configuration illustrated in FIG. 8C.
[0079] In the embodiment illustrated in FIG. 8C, at least a portion
of the annular valve body 2020 and ventricular anchoring legs 2240
of the prosthetic valve 6000 may be retained within the distal
capsule portion. Additionally, or alternatively, at least a portion
of atrial anchoring arms 2440 may be retained within proximal
capsule portion 7320. In some embodiments, valve anchor disc 8200
may include a number of recesses 8205 configured to receive and
retain the ventricular end delivery posts 2028 of the prosthetic
valve 6000. For example, the valve anchor disc 8200 may include at
least the same number of recesses 8205 as there are delivery posts
2028 of the prosthetic valve 6000. In some embodiments, the
delivery posts 2028 may be retained within the recesses 8205 so
long as the annular valve body 2020 remains in a
radially-contracted configuration; the engagement between the valve
anchor disc 8200 and delivery posts 2028 may secure the prosthetic
valve 6000 against axial movement. Upon radial expansion of the
annular valve body 2020, the delivery posts 2028 may slide or
expand out of the recesses 8205, freeing the prosthetic valve 6000
from engagement with the valve anchor disc 8200.
[0080] FIG. 9 illustrates one exemplary advancement route of the
delivery capsule 7300 to the left atrium. In the example
illustrated in FIG. 9, the delivery capsule 7300 may be steered
through the vena cava into the right atrium 9210 and may pierce the
interatrial septum and enter the left atrium 9010. Alternatively,
the delivery capsule may be delivered to the heart by other routes.
FIG. 9 also depicts the left ventricle 9020, the mitral valve 9030,
the chordae tendineae 9022, the aortic valve 9045, and the aorta
9040.
[0081] FIGS. 10A-10H depict an exemplary implantation method of
prosthetic valve 6000 within a mitral valve 9030. In FIG. 10A, the
delivery capsule 7300 may be coaxially aligned with the mitral
valve 9030. In some embodiments, the prosthetic valve 6000 may be
held within the delivery capsule 7300 while the prosthetic valve is
arranged in the configuration of FIG. 5A. In FIG. 10B, the delivery
capsule 7300 may be distally advanced into the mitral valve 9030.
In FIG. 10C, the distal capsule portion 7340 may be distally
advanced relative to the rest of the delivery capsule 7300. This
may release the ventricular anchoring legs 2240 from the distal
capsule portion 7340, while the atrial anchoring arms 2440 and
annular valve body 2020 remain constrained within the delivery
capsule. In the example shown in FIG. 10C, the ventricular
anchoring legs 2240 may be released from the delivery capsule 7300
within the atrium 9010. In some embodiments, the prosthetic valve
6000 may assume the configuration of FIG. 5B when the ventricular
anchoring legs 2240 are released in the step depicted in FIG.
10C.
[0082] In FIG. 10D, the released ventricular anchoring legs 2240
may be passed through the mitral valve 9030 and into the left
ventricle 9020. In FIG. 10E, the released legs 2240 may be
proximally retracted until the ventricular anchoring legs come into
contact with the ventricular tissue of the mitral valve 9030. In
FIG. 10F, the proximal capsule portion 7320 may be retracted
proximally, thus releasing the atrial anchoring arms 2440 within
atrium 9010 while the annular valve body 2020 remains radially
constrained within the distal capsule portion 7340. In some
embodiments, the prosthetic valve 6000 may assume the configuration
of FIG. 5D when the atrial anchoring arms 2440 are released in the
step of FIG. 10F.
[0083] In FIG. 10G, the distal capsule portion 7340 may be advanced
further until the annular valve body 2020 is released from the
capsule and allowed to radially expand. Radial expansion of the
annular valve body 2020 may allow the prosthetic valve to assume
the fully-expanded configuration illustrated in FIG. 5E. At this
stage, prosthetic valve 6000 may be securely implanted within
mitral valve 9030. In FIG. 10H, the delivery system 7000, including
capsule 7300, may be removed.
[0084] Various embodiments of the present disclosure relate to
prosthetic valves, including prosthetic heart valves. While the
present disclosure provides examples of prosthetic heart valves,
and in particular prosthetic mitral valves, it should be noted that
aspects of the disclosure in their broadest sense are not limited
to a prosthetic heart valve. Rather, the foregoing principles may
be applied to other prosthetic valves as well. Prosthetic heart
valve 6000, illustrated in FIGS. 6A-6E, is one example of a
prosthetic valve in accordance with the present disclosure.
[0085] In some embodiments, an exemplary prosthetic valve may be
configured for implantation within a native atrioventricular valve
and may regulate blood flow between the atrium and ventricle. For
example, prosthetic heart valve 6000 illustrated in FIGS. 6A-6C may
include a fluid-impervious cuff 6200 configured to extend from an
inner lumen 2022 of the prosthetic valve to terminal arm ends 2444
of a plurality of atrial anchoring arms 2440. Because cuff 6200 is
constructed of a fluid-impervious material, cuff 6200 may be
configured to minimize or block flow of blood and other fluids
through any portion of the prosthetic valve 6000 except for lumen
2022. In addition, atrial anchoring arms 2440 of the prosthetic
valve (including terminal arm ends 2444) may be configured to
contact and, in some embodiments, press against atrial tissue of a
native heart valve. This is illustrated in FIGS. 10G-10H, which
depict atrial anchoring arms 2440 of prosthetic valve 6000 arranged
in contact with, and exerting a ventricularly-directed force (that
is, a force directed downwards toward ventricle 9020) upon atrial
tissue of native mitral valve 9030. As a result, cuff 6200 of
prosthetic valve 6000 may also be configured to minimize or block
passage of blood and other fluids between the prosthetic valve 6000
(including terminal arm ends 2444) and native valve tissue, a
condition known as perivalvular leakage. As a result, prosthetic
valve 6000 may be configured to prohibit passage of blood and other
fluids between atrium 9010 and ventricle 9020, except by passage
through inner lumen 2022, in which leaflets 6602, 6604, and 6606
may be situated.
[0086] In some embodiments, an exemplary prosthetic valve may be
expandable, such as between a radially-contracted configuration
(e.g., a crimped state) and a radially-expanded configuration. For
example, FIG. 5A illustrates a radially-contracted configuration of
an exemplary prosthetic valve, and FIG. 5E illustrates a
radially-expanded configuration of the exemplary prosthetic valve.
The diameter of the prosthetic valve, including annular valve body
2020, ventricular anchoring legs 2240, and atrial anchoring arms
2440, may be reduced when the prosthetic valve assumes the
radially-contracted configuration, as illustrated in FIG. 5A. The
diameter of the prosthetic valve may be increased when the
prosthetic valve assumes the radially-expanded configuration, as
illustrated in FIG. 5E. For example, an annular valve body 2020 of
the prosthetic valve may radially expand when the prosthetic valve
assumes the radially-expanded configuration. Additionally, or
alternatively, a plurality of ventricular anchoring legs 2240
and/or atrial anchoring arms 2440 may be configured to deflect
radially outward from the exemplary annular valve body 2020 when
the prosthetic valve assumes the radially-expanded
configuration.
[0087] In some embodiments, the exemplary prosthetic valve may be
configured to be radially contracted into a radially-contracted
configuration for introduction to an implantation site, such as on
or within a delivery device. Accordingly, in some embodiments, the
radially-contracted configuration may also be a delivery
configuration, in which the prosthetic valve is arranged for
delivery to the implantation site. Once at or near the implantation
site, the prosthetic valve may be radially expanded to a
radially-expanded configuration, in which the prosthetic valve may
be anchored at the implantation site. Accordingly, in some
embodiments, the radially-expanded configuration may also be a
deployed configuration, in which the prosthetic valve is released
from the delivery tool and seated at the implantation site.
[0088] In some embodiments, an exemplary prosthetic valve may be
configured for self-expansion to the radially-expanded
configuration; that is, the prosthetic valve may be biased to
assume the radially-expanded configuration due to, at least in
part, the design and/or material composition of the prosthetic
valve. The self-expanding prosthetic valve may be constructed of a
shape memory material such as nickel titanium alloy (Nitinol),
which may permit the prosthetic valve to expand to a pre-determined
diameter upon removal of a constraining force and/or application of
heat or energy. For example, the prosthetic valve may be contracted
and held in the radially-contracted configuration by a constraining
device, such as a sheath, catheter, stent, or delivery capsule. An
example of such a constraining device is illustrated in FIG. 8C,
which illustrates prosthetic heart valve 6000 held in a
radially-contracted configuration within delivery capsule 7300.
When the prosthetic valve is positioned at or near the implantation
site, the constraining force may be removed and the prosthetic
valve allowed to self-expand to the radially-expanded
configuration. Additionally, or alternatively, an exemplary
prosthetic valve may be configured to expand due to application of
radially expansive forces thereupon. For example, the prosthetic
valve may be placed, in its radially-contracted configuration, upon
an expansion device such as a balloon catheter. Upon positioning at
the implantation site, the expansion device may exert an
outwardly-directed force upon the prosthetic valve, causing it to
expand to the radially-expanded configuration.
[0089] In some embodiments, the exemplary prosthetic valve may be
configured for implantation at a treatment site within the body,
such as within or adjacent to a native heart valve structure. In
some embodiments, a prosthetic valve may be configured for
transcatheter delivery to the implantation site via a variety of
approaches, such as transapically, transatrially, and/or
transseptally. In some embodiments, the prosthetic valve may be
configured for implantation in the annulus or orifice of a native
heart valve structure (e.g., a native heart valve). For example, in
FIGS. 10A-10H, prosthetic valve 6000 may be delivered to and
expanded within native mitral valve 9030 such that prosthetic valve
6000 is anchored within native mitral valve 9030. In some
embodiments, the exemplary prosthetic valve may be configured to
grasp tissue of the native heart valve to more firmly anchor the
prosthetic valve within the native heart valve. For example, an
exemplary prosthetic valve may be configured to grasp the native
leaflets and/or native heart valve annulus to firmly seat the
prosthetic valve within the valve annulus, thus preventing the
prosthetic valve from migrating or dislodging from within the
native heart valve annulus.
[0090] In some embodiments, an exemplary prosthetic heart valve may
include an annular outer frame and an inner frame positioned at
least partially within the annular outer frame. In some
embodiments, the inner frame may be positioned partially within the
annular outer frame. Alternatively, the inner frame may be
positioned entirely within the annular outer frame. One or both of
the inner frame and the outer frame may be annular or ring-shaped
and may both include at least one opening. In some embodiments, the
inner frame may be positioned within an opening of the annular
outer frame. For example, FIG. 2A depicts an exemplary prosthetic
valve frame 2000 having an outer frame 2200 and an inner frame
2400. As illustrated in FIG. 2B, inner frame 2400 and outer frame
2200 may both be annular, with inner frame 2400 situated at least
partially within outer frame 2200. Because outer frame 2200 and
inner frame 2400 are both annular, axial lumen 2022 may extend
longitudinally along the entire respective lengths of the outer
frame 2200 and inner frame 2400. The inner and outer frames may be
constructed of various materials, such as polymeric or metal
materials. For example, the inner and outer frames may be
constructed of a material that is biocompatible and/or has
shape-memory properties. In some embodiments, the inner and outer
frames may be constructed, at least partially, of a shape-memory
material, such as Nitinol. Additionally, or alternatively, the
inner and outer frames may be constructed, at least partially, of
stainless steel, chromium alloys, and/or other suitable
materials.
[0091] In some embodiments, the inner and outer frames may be
expandable, such as between respective radially-contracted
configurations (e.g., crimped states) and radially-expanded
configurations. For example, the inner and outer frames may be
configured to transition between the radially-contracted and
radially-expanded configurations together due, at least in part, to
one or more connections between the frames. For example, FIG. 5A
illustrates an inner frame 2400 and outer frame 2200 in respective
radially-contracted configurations, while FIG. 5E illustrates inner
frame 2400 and outer frame 2200 in respective radially-expanded
configurations. The respective diameters of the inner and outer
frames may be reduced when the inner and outer frames are arranged
in their respective radially-contracted configurations. For
example, the inner and outer frames may be arranged in the
radially-contracted configurations when the exemplary prosthetic
heart valve is delivered to the implantation site. Additionally,
the respective diameters of the inner and outer frames may be
increased when the inner and outer frames assume their respective
radially-expanded configurations. In some embodiments, the inner
frame and outer frame may be fully radially-expanded when the inner
frame and outer frame are arranged in their radially-expanded
configurations.
[0092] In some embodiments, the inner frame and outer frame may be
configured for self-expansion to their respective radially-expanded
configurations; that is, the inner and outer frames may be biased
to assume their respective radially-expanded configurations due to,
at least in part, the design and/or material composition of the
inner and outer frames. The self-expanding frames may be
constructed of a shape memory material such as nickel titanium
alloy (Nitinol), which may permit the inner and outer frames to
expand to pre-determined diameters upon removal of a constraining
force and/or application of heat or energy. For example, the inner
frame and outer frame may be contracted and held in their
respective radially-contracted configurations by a constraining
device, such as a sheath, catheter, stent, or delivery capsule. An
example of such a constraining device is illustrated in FIG. 8C,
which illustrates an inner frame 2400 and outer frame 2200 of an
exemplary prosthetic heart valve held in their respective
radially-contracted configurations within a delivery capsule 7300.
When the inner frame and outer frame are positioned at or near the
implantation site (e.g., at the native mitral valve 9030 of FIG.
9), the constraining force (e.g., as applied by delivery capsule
7300) may be removed and the inner frame and outer frame allowed to
self-expand to their respective radially-expanded configurations.
Additionally, or alternatively, exemplary inner and outer frames
may be configured to expand due to application of radially
expansive forces thereupon. For example, the inner frame and outer
frame may be placed, in their radially-contracted configurations,
upon an expansion device such as a balloon catheter. Upon
positioning at the implantation site, the expansion device may
exert an outwardly-directed force upon the inner and outer frames,
causing them to expand to their fully-expanded configurations.
[0093] In some embodiments, the annular outer frame may include an
outer frame tubular portion. The outer frame tubular portion may
have a circular, oval-shaped, elliptical, or D-shaped cross-section
and may have at least one opening extending longitudinally through
the outer frame tubular portion. In some embodiments, the outer
frame tubular portion may be symmetrical about at least one axis of
the outer frame tubular portion. For example, the exemplary outer
frame 2200 illustrated in FIG. 3C may include an outer frame
tubular portion 3605. Outer frame tubular portion 3605 may have a
substantially circular cross-sectional shape with a central opening
and may be symmetrical about the longitudinal axis of the outer
frame tubular portion. In some embodiments, at least a portion of
the outer frame tubular portion may be cylindrical, with a
substantially constant diameter along the entire length of the
outer frame tubular portion. Alternatively, the outer frame tubular
portion may have a variable diameter at different portions of the
outer frame tubular portion (e.g., at different longitudinal
portions of the outer frame tubular portion).
[0094] The outer frame tubular portion may be formed of a plurality
of supporting members or struts. In some embodiments, the struts
may intersect at junctions to form a wire mesh, stent-like, or
cage-like structure of the outer frame tubular portion. A junction
may be formed at a location at which at least two struts terminate;
that is, exemplary struts may extend to and terminate at a junction
at which they intersect with one or more other struts. For example,
as illustrated in FIG. 3C, outer frame 2200 may include outer frame
atrial circumferential struts 3608a, outer frame leg base struts
3608b, and outer frame ventricular circumferential struts 3608c
intersecting at atrial end outer frame junctions 3602, leg
attachment junctions 3802, outer frame junctions 3804, and
ventricular end outer frame junctions 3604 to form outer frame
tubular portion 3605.
[0095] In some embodiments, the annular outer frame may include a
plurality (that is, one or more) of ventricular anchoring legs
configured to extend radially outward from the outer frame tubular
portion of the annular outer frame. For example, FIGS. 2A and 3C
illustrate an annular outer frame 2200 having an outer frame
tubular portion 3605 and a plurality of ventricular anchoring legs
2240 extending radially outward from the outer frame tubular
portion of the annular outer frame. The ventricular anchoring legs
may be configured to anchor the prosthetic valve at an implantation
site, such as within or near a native heart valve. For example, the
ventricular anchoring legs may be configured to engage ventricular
tissue of a native heart valve to anchor the prosthetic valve
within the heart valve. In some embodiments, the ventricular
anchoring legs may be configured to be positioned at least
partially within a ventricle upon implantation of the prosthetic
valve within or near a native heart valve, and to engage
ventricular tissue of the heart valve. For example, FIGS. 10E-10H
depict ventricular anchoring legs 2240 of an exemplary prosthetic
heart valve 6000. Ventricular anchoring legs 2240 are situated
within ventricle 9020 and may engage the ventricular side of native
mitral valve 9030 to secure prosthetic heart valve 6000 within the
mitral valve.
[0096] The prosthetic valve may include one ventricular anchoring
leg, two ventricular anchoring legs, three ventricular anchoring
legs, four ventricular anchoring legs, five ventricular anchoring
legs, six ventricular anchoring legs, seven ventricular anchoring
legs, eight ventricular anchoring legs, nine ventricular anchoring
legs, ten ventricular anchoring legs, eleven ventricular anchoring
legs, twelve ventricular anchoring legs, thirteen ventricular
anchoring legs, fourteen ventricular anchoring legs, fifteen
ventricular anchoring legs, sixteen ventricular anchoring legs,
seventeen ventricular anchoring legs, eighteen ventricular
anchoring legs, nineteen ventricular anchoring legs, twenty
ventricular anchoring legs, or any other suitable number of
ventricular anchoring legs. For example, exemplary prosthetic valve
6000 depicted in FIG. 2B includes twelve ventricular anchoring legs
2240.
[0097] In some embodiments, the ventricular anchoring legs may be
configured to extend radially outward from the outer frame tubular
portion to respective terminal leg ends. In some embodiments, the
term "radially outward" may refer to a direction extending away
from the center of the annular outer frame (for example, away from
the longitudinal axis of the exemplary prosthetic valve). In some
embodiments, the ventricular anchoring legs may be connected to the
outer frame tubular portion and configured to extend radially
outward from the outer frame tubular portion. For example, in FIGS.
5D and 5E, ventricular anchoring legs 2240 may be connected to
outer frame tubular portion 3605 at leg attachment junctions 3802
and may extend radially outward from the outer frame tubular
portion 3605. In some embodiments, the ventricular anchoring legs
may be physically connected to the outer frame tubular portion,
such as by welding or adhesive. In some alternative embodiments,
the ventricular anchoring legs may be integrally formed with the
outer frame tubular portion. In some further alternative
embodiments, the ventricular anchoring legs may not be secured
directly to the outer frame tubular portion; however, the
ventricular anchoring legs may be configured to extend in a
radially outward direction from the outer frame tubular
portion.
[0098] In some embodiments, the locations of connection between the
ventricular anchoring legs and outer frame tubular portion may be
spaced at a regular interval about a circumference of the annular
outer frame. For example, in FIGS. 2A and 3C, the ventricular
anchoring legs 2240 may extend from the outer frame tubular portion
3605 at leg attachment junctions 3802. Leg attachment junctions
3802 may be spaced at a regular interval about the circumference of
outer frame tubular portion 3605. Additionally, or alternatively,
the locations of connection between the ventricular anchoring legs
and outer frame tubular portion may be arranged along a plane
perpendicular to the longitudinal axis of the prosthetic valve. For
example, in FIG. 2A, the leg attachment junctions 3802 may be
arranged along a plane perpendicular to longitudinal axis 2800.
That is, the leg attachment junctions 3802 may be situated at the
same axial position along longitudinal axis 2800.
[0099] In some embodiments, each ventricular anchoring leg may
include a proximal leg end connected to or otherwise secured
relative to the outer frame tubular portion, and a terminal leg end
configured to extend radially outward from the outer frame tubular
portion and, thus, from the proximal leg end of the ventricular
anchoring leg. In various embodiments, a proximal leg end may refer
to a portion of a ventricular anchoring leg situated in closest
proximity to the outer frame tubular portion and may, in some
embodiments, include a point of connection between the ventricular
anchoring leg and the outer frame tubular portion. In various
embodiments, a terminal leg end may refer to a portion of a
ventricular anchoring leg furthest from the point of connection
between the leg and the outer frame tubular portion. For example,
ventricular anchoring legs 2240 illustrated in FIGS. 2A and 3C may
include a proximal leg end 3622 connected to outer frame tubular
portion 3605 (e.g., at leg attachment junction 3802) and a terminal
leg end 2244 configured to extend radially outward from the outer
frame tubular portion 3605 and from the proximal leg end 3622.
[0100] In some embodiments, the inner frame may include an inner
frame tubular portion. The inner frame tubular portion may have a
circular, oval-shaped, elliptical, or D-shaped cross-section and
may have at least one opening extending longitudinally through the
inner frame tubular portion. In some embodiments, the inner frame
tubular portion may be symmetrical about at least one axis of the
inner frame tubular portion. For example, the exemplary inner frame
2400 illustrated in FIG. 3A may include an inner frame tubular
portion 3005. Inner frame tubular portion 3005 may have a
substantially circular cross-sectional shape with a central opening
and may be symmetrical about the longitudinal axis of the inner
frame tubular portion. In some embodiments, at least a portion of
the inner frame tubular portion may be cylindrical, with a
substantially constant diameter along the entire length of the
inner frame tubular portion. Alternatively, the inner frame tubular
portion may have a variable diameter at different portions of the
inner frame tubular portion (e.g., at different longitudinal
portions of the inner frame tubular portion).
[0101] The inner frame tubular portion may be formed of a plurality
of struts intersecting at junctions to form a wire mesh,
stent-like, or cage-like structure of the inner frame tubular
portion. For example, as illustrated in FIG. 3A, inner frame 2400
may include inner frame atrial struts 3008a, inner frame
intermediate struts 3008b, and inner frame ventricular struts 3008c
intersecting at atrial end inner frame junctions 3002, arm
attachment junctions 3202, inner frame strut junctions 3204, and
ventricular end inner frame junctions 3004 to form inner frame
tubular portion 3005.
[0102] The exemplary inner frame may be configured to receive or
otherwise support a flow control device, such as one or more
leaflets, for regulating flow of blood or other bodily fluids
through the prosthetic heart valve. For example, the flow control
device (e.g., leaflets) may be secured directly to the inner frame
and/or to an intermediate structure (e.g., a liner) that is in turn
secured to the inner frame. For example, FIG. 6C illustrates an
embodiment in which leaflets 6602 and 6604 (as well as 6606, which
is not depicted in FIG. 6C) are arranged within inner frame 2400.
As a result, when the prosthetic heart valve is implanted within a
native valve, the flow control device (e.g., leaflets) may regulate
fluid passage through the native valve, thus restoring and/or
replacing the functionality of the native valve. In the example of
a prosthetic mitral valve, the flow control device situated within
the inner frame may be configured to permit flow of blood and other
fluids in one direction (e.g., from the left atrium to the left
ventricle) and to prevent flow of blood and other fluids in a
second, opposite direction (e.g., from the left ventricle to the
left atrium).
[0103] In some embodiments, the inner frame may include a plurality
(that is, one or more) of atrial anchoring arms configured to
extend radially outward from the inner frame tubular portion of the
exemplary inner frame. For example, FIGS. 2A and 3A illustrate an
inner frame 2400 having an inner frame tubular portion 3005 and a
plurality of atrial anchoring arms 2440 extending radially outward
from the inner frame tubular portion. The atrial anchoring arms may
be configured to anchor the prosthetic valve at an implantation
site, such as within or near a native heart valve. For example, the
atrial anchoring arms may be configured to engage atrial tissue of
a native heart valve to anchor the prosthetic valve within the
heart valve. In some embodiments, the atrial anchoring arms may be
configured to be positioned at least partially within an atrium
upon implantation of the prosthetic valve within or near a native
heart valve, and to engage atrial tissue of the heart valve. For
example, FIGS. 10F-10H depict atrial anchoring arms 2440 of an
exemplary prosthetic heart valve 6000. Atrial anchoring arms 2440
are situated within atrium 9010 and may engage the atrial side of
native mitral valve 9030 to secure prosthetic heart valve 6000
within the mitral valve.
[0104] The prosthetic valve may include one atrial anchoring arm,
two atrial anchoring arms, three atrial anchoring arms, four atrial
anchoring arms, five atrial anchoring arms, six atrial anchoring
arms, seven atrial anchoring arms, eight atrial anchoring arms,
nine atrial anchoring arms, ten atrial anchoring arms, eleven
atrial anchoring arms, twelve atrial anchoring arms, thirteen
atrial anchoring arms, fourteen atrial anchoring arms, fifteen
atrial anchoring arms, sixteen atrial anchoring arms, seventeen
atrial anchoring arms, eighteen atrial anchoring arms, nineteen
atrial anchoring arms, twenty atrial anchoring arms, or any other
suitable number of atrial anchoring arms. For example, exemplary
prosthetic valve 6000 depicted in FIG. 2B includes twelve atrial
anchoring arms 2440.
[0105] In some embodiments, the atrial anchoring arms may be
configured to extend radially outward from the inner frame tubular
portion of the exemplary inner frame. In some embodiments, the
atrial anchoring arms may be connected to the inner frame tubular
portion and configured to extend radially outward from the inner
frame tubular portion. For example, in FIGS. 5D and 5E, atrial
anchoring arms 2440 may be connected to inner frame tubular portion
3005 at arm attachment junctions 3202 and may extend radially
outward from the inner frame tubular portion 3005. In some
embodiments, the atrial anchoring arms may be physically connected
to the inner frame tubular portion, such as by welding or adhesive.
In some alternative embodiments, the atrial anchoring arms may be
integrally formed with the inner frame tubular portion. In some
further alternative embodiments, the atrial anchoring arms may not
be secured directly to the inner frame tubular portion; however,
the atrial anchoring arms may be configured to extend in a radially
outward direction from the inner frame tubular portion.
[0106] In some embodiments, the locations of connection between the
atrial anchoring arms and inner frame tubular portion may be spaced
at a regular interval about a circumference of the inner frame. For
example, in FIGS. 2A and 3A, the atrial anchoring arms 2440 may
extend from the inner frame tubular portion 3005 at arm attachment
junctions 3202. Arm attachment junctions 3202 may be spaced at a
regular interval about the circumference of inner frame tubular
portion 3005. Additionally, or alternatively, the locations of
connection between the atrial anchoring arms and inner frame
tubular portion may be arranged along a plane perpendicular to the
longitudinal axis of the prosthetic valve. For example, in FIG. 2A,
the arm attachment junctions 3202 may be arranged along a plane
perpendicular to longitudinal axis 2800. That is, the arm
attachment junctions 3202 may be situated at the same axial
position along longitudinal axis 2800.
[0107] In some embodiments, each atrial anchoring arm may include a
proximal arm end connected to or otherwise secured relative to the
inner frame tubular portion, and a terminal arm end configured to
extend radially outward from the inner frame tubular portion and,
thus, from the proximal arm end of the atrial anchoring arm. For
example, atrial anchoring arms 2440 illustrated in FIGS. 2A and 3A
may include a proximal arm end 3020 connected to inner frame
tubular portion 3005 (e.g., at arm attachment junction 3202) and a
terminal arm end 2444 configured to extend radially outward from
the inner frame tubular portion 3005 and from the proximal arm end
3020.
[0108] According to various embodiments, the inner frame of the
prosthetic heart valve may be connected to the annular outer frame
such that they may be delivered to the implantation site together
and may be configured to radially expand and contract together. For
example, the inner and outer frames may be connected by pins,
screws, welding, soldering, adhesive, magnets, and/or any other
suitable mechanism. The inner and outer frames may be secured
together at multiple points of the inner frame and outer frame. For
example, FIG. 2A depicts inner frame 2400 and outer frame 2200
connected by a plurality of connector pins 2040, each situated at a
different circumferential position of the valve frame 2000 and each
configured to extend between the inner 2400 and outer 2200 frames
to secure them together. In the example of FIG. 2A, inner frame
2400 and outer frame 2200 may be connected together by twelve
connector pins 2040. Alternatively, any suitable number of
connector pins may be utilized to secure the inner and outer frames
together.
[0109] In some embodiments, inner frame tubular portion 3005 and
outer frame tubular portion 3605 may together form an annular valve
body 2020. The annular valve body 2020 may have at least one
opening. In some embodiments, the at least one opening may extend
longitudinally along the entire length of the annular valve body.
For example, FIG. 2B illustrates an exemplary frame 2000 of a
prosthetic heart valve. Heart valve frame 2000 may include an
annular valve body 2020 having an axial lumen 2022 extending
longitudinally through the annular valve body 2020. The annular
valve body may be sized and configured to be seated within the
orifice of a native mitral valve. For example, as depicted in FIG.
10H, annular valve body 2020 may be situated within the orifice of
mitral valve 9030, specifically between native leaflets 9032. In
some embodiments, the annular valve body may be configured to have
a smaller diameter, when fully-expanded, than the diameter of the
orifice of the native mitral valve. In such embodiments, the
annular valve body may be anchored in the native mitral valve by
anchoring structures, such as atrial anchoring arms and/or
ventricular anchoring legs. Alternatively, the annular valve body
may be configured to expand to an equal or greater diameter than
the diameter of the heart mitral orifice such that the annular
valve body is anchored within the mitral valve.
[0110] In some embodiments, a portion of each of the plurality of
ventricular anchoring legs may be configured to overlap with a
portion of each of the plurality of atrial anchoring arms in a
common lateral plane. That is, the atrial anchoring arms and
ventricular anchoring legs may be configured to assume a
configuration in which a portion of each atrial anchoring arm and a
portion of each ventricular anchoring leg are aligned in a plane
that is perpendicular to the longitudinal axis of the prosthetic
valve. Said another way, a portion of each atrial anchoring arm and
a portion of each ventricular anchoring leg may be arranged at the
same axial position relative to the longitudinal axis of the
prosthetic valve. An example of such a configuration is illustrated
in FIG. 2C, which depicts an exemplary ventricular anchoring leg
2240 having a portion 2246 aligned in a common lateral plane with a
portion 2446 of an exemplary atrial anchoring arm 2440, the common
lateral plane being perpendicular to the longitudinal axis 2800
illustrated in FIG. 2A. That is, arm portion 2446 and leg portion
2246 may be arranged at the same axial position relative to
longitudinal axis 2800. In some embodiments, the portion of each
ventricular anchoring leg that is arranged in the common lateral
plane may include the terminal end of the leg; alternatively, the
portion of each ventricular anchoring leg that is arranged in the
common lateral plane may include a section of the leg situated
radially inwards from the terminal end of the leg (such as leg
portion 2246 illustrated in FIG. 2C). In some embodiments, the
portion of each atrial anchoring arm that is arranged in the common
lateral plane (e.g., portion 2446 in FIG. 3C) may be situated in an
outer radial half of the atrial anchoring arm. In some embodiments,
a portion of each ventricular anchoring leg (e.g., terminal leg
ends 2244) may be configured to extend in an atrial direction
beyond the portions of the arms arranged in the common lateral
plane (e.g., arm portion 2446, which may be situated below terminal
leg end 2244 in FIG. 3C).
[0111] In some embodiments, the atrial anchoring arms and
ventricular anchoring legs may be biased to assume the
aforementioned overlapping configuration (as illustrated in FIG.
2C) due at least in part to the shape-memory properties of the
atrial anchoring arms and ventricular anchoring legs. However, upon
implantation of the prosthetic valve, the prosthetic valve may
grasp and retain native valve tissue between the atrial anchoring
arms and ventricular anchoring legs. For example, FIGS. 10G and 10H
illustrate tissue of mitral valve 9030 retained between atrial
anchoring arms 2440 and ventricular anchoring legs 2240. The
retained tissue may slightly deform the atrial anchoring arms 2440
and ventricular anchoring legs 2240, pushing the arms and legs
axially apart from each other (and thus, out of the configuration
illustrated in FIG. 2C). However, due to their shape memory
characteristics, the atrial anchoring arms 2440 and ventricular
anchoring legs 2240 may resist the deformation and exert respective
clamping forces on the retained tissue. For example, atrial
anchoring arms 2440 may clamp tissue by exerting a
ventricularly-directed force (that is, a force directed downwards
towards ventricle 9020 in FIGS. 10G and 10H) on the heart valve
tissue. Similarly, ventricular anchoring legs 2240 may clamp the
tissue by exerting an atrially-directed force (that is, a force
directed upwards towards atrium 9010 in FIGS. 10G and 10H) on the
heart valve tissue. The opposing forces exerted by the atrial
anchoring arms and ventricular anchoring legs may clamp or
"sandwich" the heart valve tissue between the atrial anchoring arms
and ventricular anchoring legs, thus firmly anchoring prosthetic
heart valve 6000 against axial and lateral movement within the
native heart valve.
[0112] In some embodiments, the atrial anchoring arms and
ventricular anchoring legs may be configured to extend radially
outward from the inner frame and from the annular outer frame,
respectively. For example, as illustrated in FIG. 2A, atrial
anchoring arms 2440 may be configured to extend radially outward
from the inner frame 2400, in particular from the arm attachment
junctions 3202. In addition, ventricular anchoring legs 2240 may be
configured to extend radially outward from the annular outer frame
2200, in particular from the leg attachment junctions 3802.
[0113] In some embodiments, the exemplary prosthetic valve may have
an axial length of two centimeters or less. In some embodiments,
the axial length of the prosthetic valve may refer to the axial
length spanned by the annular valve body, atrial anchoring arms,
and ventricular anchoring legs. For example, in FIG. 2D, length
2560 may correspond to the axial length of the prosthetic valve. In
some embodiments, the prosthetic valve of FIG. 2D may have an axial
length 2560 of two centimeters or less. In some embodiments, the
axial length of the prosthetic valve may extend between the
terminal ends of the atrial anchoring arms and the ventricular end
of the annular valve body. For example, in FIG. 2D, length 2560 may
extend between terminal arm ends 2444 and the ventricular end 2025
of annular valve body 2020. Terminal arm ends 2444 may constitute
the atrial end of the prosthetic valve (that is, the uppermost
portion of the prosthetic valve in FIG. 2D). Annular valve body
ventricular end 2025 may constitute the ventricular end of the
prosthetic valve (that is, the lowermost portion of the prosthetic
valve in FIG. 2D). In some embodiments, ventricular end delivery
posts 2028 may not be incorporated within the axial length of the
prosthetic valve because delivery posts 2028 are configured for
engagement with the prosthetic valve delivery device and do not
constitute a portion of the prosthetic valve configured to restore
and/or replace the functionality of a native valve.
[0114] Advantageously, because the exemplary prosthetic valve has
an axial length of two centimeters or less, the prosthetic valve
may protrude a short distance into the atrium and ventricle after
implantation in a native atrioventricular valve (e.g., a mitral
valve). Due to the short axial length of the prosthetic valve, the
prosthetic valve is prevented from coming in contact with, and
causing injury to, the native heart anatomy after the prosthetic
valve is implanted. Such heart anatomy may include the walls of the
atrium and ventricle, as well as the chordae tendineae. In
addition, because the prosthetic valve has a short axial length,
the delivery device of the prosthetic valve may similarly have a
short axial length. For example, as illustrated in FIG. 8C,
exemplary prosthetic valve 6000 may be delivered to the
implantation site within delivery capsule 7300. Because the
prosthetic valve may have an axial length of two centimeters or
less, the delivery capsule may have an axial length of five
centimeters or less; in contrast, a prosthetic valve with an axial
length longer than two centimeters would require a delivery capsule
longer than five centimeters. Advantageously, the exemplary
delivery capsule may require less space to maneuver within the left
atrium to align the prosthetic valve with the mitral valve during
implantation, as compared to a longer delivery device. In
particular, because the exemplary delivery capsule has an axial
length of five centimeters or less, it may be inserted into and
maneuvered within the left atrium without pushing against the
atrial wall, which may scratch the atrial wall and can cause
fibrillation.
[0115] The exemplary prosthetic valve includes several features,
the combination of which enables the prosthetic valve to have an
axial length of two centimeters or less. For example, a portion of
each of the plurality of ventricular anchoring legs 2240 may
overlap with a portion of each of the plurality of atrial anchoring
arms 2440 in a common lateral plane when the prosthetic valve is in
a radially-expanded configuration, as discussed above in reference
to FIG. 2C. Because the atrial anchoring arms 2440 and ventricular
anchoring legs 2240 are configured to overlap in this fashion, the
axial length of the prosthetic valve may be reduced since it is not
necessary for the prosthetic valve to include additional length to
keep the atrial anchoring arms and ventricular anchoring legs
separate.
[0116] In addition, the exemplary prosthetic valve may be
configured to have an axial length of two centimeters or less due
to the small radius of the annular valve body 2020 and the length
of the atrial anchoring arms 2440. As illustrated in FIGS. 6D and
6E, prosthetic leaflets 6602, 6604, and 6606 may be situated within
lumen 2022 of the annular valve body 2020. In order for the
leaflets 6602, 6604, and 6606 to be configured to coapt (that is,
to assume the closed leaflet arrangement illustrated in FIG. 6E),
the annular valve body 2020 may be configured to have an axial
length (represented by height 2530 in FIG. 2D) equal to or larger
than the radius of the leaflets situated within the annular valve
body. If the axial length of the annular valve body 2020 were
configured to be smaller than the radius of the leaflets 6602,
6604, and 6606, the leaflets may be unable to fully close, thus
preventing the prosthetic valve from regulating blood flow through
the heart.
[0117] Accordingly, in some embodiments, annular valve body 2020
may have a small inner radius, which may allow the prosthetic valve
to have an axial length of two centimeters or less. For example,
and as illustrated in FIG. 2D, the atrial inlet opening 2032 of the
annular valve body may have a radius 2520 of 15 millimeters or
less, with leaflets 6602, 6604, and 6606 having a radius of between
10 millimeters and 18 millimeters. This may allow annular valve
body 2020 to have an axial height 2530 of 20 millimeters or less,
and the prosthetic valve to have an axial height 2560 of 20
millimeters (i.e., two centimeters) or less, while still enabling
leaflets 6602, 6604, and 6606 to coapt into the closed leaflet
arrangement illustrated in FIG. 6E. In accordance with these
embodiments, if the atrial inlet opening 2032 of the annular valve
body were enlarged, without also increasing the axial length 2560
of the prosthetic valve to be longer than two centimeters, leaflets
6602, 6604, and 6606 may be unable to coapt. In a particular
embodiment, the radius 2520 of the annular valve body may be 13.5
millimeters, the leaflets 6602, 6604, and 6606 may have a radius of
13 millimeters, and the axial height 2530 may be 15 millimeters,
for example.
[0118] However, due to the small radius of the annular valve body
2020, the atrial anchoring arms 2440 may be configured to have a
long radial length in order for the prosthetic valve to have a
large enough diameter to remain anchored within a native heart
valve. Accordingly, in some embodiments, the atrial anchoring arms
2440 may have a length of at least 18 millimeters. In a particular
embodiment, the length of the atrial anchoring arms 2440 may be
14.5 millimeters, for example. The length of the atrial anchoring
arms may be a length extending between the proximal arm end (e.g.,
proximal arm end 3020) and the terminal arm end (e.g., terminal arm
end 2444), in a direction perpendicular to the longitudinal axis of
the prosthetic valve (as represented by length 2580 in FIG. 2E).
Because of the long length of the atrial anchoring arms 2440, the
atrial anchoring arms may be configured to engage a large
circumference of native heart valve tissue, thus preventing the
prosthetic valve from axially migrating out of the native valve
annulus (e.g., preventing the prosthetic valve from floating out of
mitral valve 9030 and into ventricle 9020).
[0119] Further, the exemplary prosthetic valve may be configured to
have an axial length of two centimeters or less due to the
arrangement of the atrial anchoring arms 2440 and ventricular
anchoring legs 2240 on the inner frame 2400 and outer frame 2200,
respectively. In some embodiments, and as illustrated in FIG. 3A,
inner frame tubular portion 3005 may be constructed of a plurality
of struts intersecting at junctions to form closed cells 3012 and
3014, which may be diamond-shaped when inner frame 2400 is in the
radially-expanded configuration depicted in FIG. 3A. When inner
frame 2400 radially expands between the radially-contracted and
radially-expanded configurations, cells 3012 and 3014 may widen (so
as to increase the radius of inner frame 2400) and may also be
reduced in height. As a result, radial expansion of inner frame
2400 may reduce the axial length of the inner frame, due to the
arrangement of the inner frame struts. Outer frame 2400 may be
similarly configured. As illustrated in FIG. 3C, outer frame
tubular portion 3605 may be constructed of a plurality of struts
intersecting at junctions to form closed cells 3616, which may be
chevron-shaped when outer frame 2200 is in the radially-expanded
configuration depicted in FIG. 3C. Similar to the cells of inner
frame 2400, outer frame cells 3616 may be widened and reduced in
height when the outer frame 2200 radially expands. Thus, radial
expansion of outer frame 2200 may reduce the axial length of the
outer frame, due to the arrangement of the outer frame struts.
[0120] In some embodiments, radial expansion of annular valve body
2020 (which may include inner frame tubular portion 3005 and outer
frame tubular portion 3605) may decrease the distance between the
atrial anchoring arms 2440 and ventricular anchoring legs 2240. For
example, FIG. 5D illustrates a configuration in which arms 2440 and
legs 2240 are radially-expanded, but annular valve body 2020
remains radially-contracted. In this configuration, the prosthetic
valve may include an axial distance 5004 between the arms 2440 and
legs 2240, with the terminal leg ends 2244 situated in a
ventricular direction from the arms 2440. In some embodiments, when
the prosthetic valve is arranged in the configuration of FIG. 5D,
native valve tissue may be retained between atrial anchoring arms
2440 and ventricular anchoring legs 2240, thus holding the
prosthetic valve within the native heart valve. However, the
prosthetic valve may still be repositioned relative to the native
heart valve in the configuration of FIG. 5D, since the heart valve
tissue is not yet clamped between the arms 2440 and legs 2240. As
illustrated in FIG. 5E, radial expansion of the annular valve body
2020 may reduce or eliminate the distance 5004 between the arms and
legs; instead, the atrial anchoring arms 2440 and ventricular
anchoring legs 2240 may be arranged in the aforementioned
overlapping configuration, with the arms 2440 and legs 2240
arranged in a common lateral plane, after annular valve body 2020
is radially expanded. As a result, native valve tissue may be
clamped or sandwiched between the arms 2440 and leg 2240, thus
securely anchoring the prosthetic valve within the native heart
valve.
[0121] As discussed above, radial expansion of the inner frame 2400
and outer frame 2200 may result in axial shortening of the inner
and outer frames. This axial shortening of the inner and outer
frames may cause features mounted on the inner and outer frames to
be positioned further apart when the frames are radially-contracted
and to be drawn closer together when the frames are
radially-expanded. For example, with reference to FIG. 3A, atrial
anchoring arms 2440 may be positioned further away from other
portions of the inner frame, such as the atrial end inner frame
junctions 3002 and ventricular end inner frame junctions 3004, when
the inner frame 2400 is radially-contracted. Radial expansion of
the inner frame 2400 may axially displace the atrial anchoring arms
2440, drawing the arms closer to the other portions of the inner
frame (such as junctions 3002 and 3004) due to the axial shortening
of the inner frame. With reference to FIG. 3C, ventricular
anchoring legs 2240 may similarly be positioned further from other
portions of the outer frame 2200 when the outer frame is
radially-contracted. Radial expansion of the outer frame 2200 may
axially displace the ventricular anchoring legs 2240, drawing legs
arms closer to other portions of the outer frame 2200 due to the
axial shortening of the outer frame.
[0122] In some embodiments, arrangement of the atrial anchoring
arms 2440 and ventricular anchoring legs 2240 on separate frames
may allow the prosthetic valve to provide distance 5004 between the
arms and legs while the annular valve body 2020 is
radially-contracted, and to reduce or remove distance 5004 upon
radial expansion of the annular valve body 2020. In some
embodiments, when the annular valve body 2020 is radially-expanded,
the axial displacement of the atrial anchoring arms 2440 caused by
expansion of the inner frame 2400 may be combined with the axial
displacement of the ventricular anchoring legs 2240 caused by
expansion of the outer frame 2200. As a result, the arms 2440 and
legs 2240 may be spaced apart prior to expansion of the annular
valve body 2020, providing distance 5004 between the atrial
anchoring arms and ventricular anchoring legs, the distance being
large enough to permit repositioning of the prosthetic valve
relative to the native heart valve. In addition, the combined axial
displacements of the atrial anchoring arms 2440 and ventricular
anchoring legs 2240 associated with expansion of the annular valve
body 2020 may allow distance 5004 to be reduced or removed when the
annular valve body is radially expanded, thus enabling the atrial
anchoring arms and ventricular anchoring legs to assume the
overlapping configuration in which the atrial anchoring arms and
ventricular anchoring legs overlap in the common lateral plane.
[0123] If the atrial anchoring arms 2440 and ventricular anchoring
legs 2240 were instead positioned in a single frame, the prosthetic
valve would not achieve the combined axial displacements of the
inner frame 2400 and outer frame 2200, discussed above. As a
result, if the atrial anchoring arms 2440 and ventricular anchoring
legs 2240 were positioned on a single frame, the axial length of
the prosthetic valve would need to be significantly extended beyond
a length of two centimeters, for example, to allow the atrial
anchoring arms and ventricular anchoring legs to be positioned
sufficiently far apart to achieve the distance 5004 between them,
and to reduce or remove the distance 5004 between the atrial
anchoring arms and ventricular anchoring legs when the single frame
is radially-expanded. Accordingly, the exemplary prosthetic valve
may be configured to have an axial length of two centimeters or
less due to the combined axial displacement associated with
positioning the atrial anchoring arms 2440 and ventricular
anchoring legs 2240 on the inner frame 2400 and outer frame 2200,
respectively.
[0124] In some embodiments, the prosthetic valve may be configured
to protrude a distance of 15 millimeters or less into a ventricle
of the heart when the prosthetic valve is implanted within a native
heart valve. In some embodiments, the distance by which the
prosthetic valve protrudes into the ventricle (known as the
"protrusion distance") may be determined by the axial distance
between the ventricular end of the prosthetic valve and a portion
of the prosthetic valve configured to engage the atrial side of a
native atrioventricular valve. For example, in FIG. 2D, length 2540
represents the protrusion distance. Accordingly, in some
embodiments protrusion distance 2540 may have a length of 15
millimeters or less. Protrusion distance 2540 may be equal to the
axial length between the ventricular end 2025 of the annular valve
body 2020 (which may include the ventricular end inner frame
junctions 3004 and the ventricular end outer frame junctions 3604)
and arm portion 3508 (which may constitute the boundary between
intermediate arm portion 3504 and distal arm portion 3506 of the
atrial anchoring arm). In some embodiments, the location of arm
portion 3508 may define one end of the protrusion distance 2540
because arm portion 3508 may be situated in a ventricular direction
relative to the rest of the intermediate arm portion 3504 and
distal arm portion 3506.
[0125] The prosthetic valve may be configured to have a protrusion
distance of 15 millimeters or less because the axial length of the
prosthetic valve may be approximately two centimeters or less. That
is, because the overall axial length of the prosthetic valve is
short (i.e., two centimeters or less), the prosthetic valve may
accordingly be configured to protrude into the ventricle by a
distance of approximately 15 millimeters or less. The remaining
axial length of the prosthetic valve (that is, the difference in
length between the axial length of the prosthetic valve and the
protrusion distance) may correspond to portions of the prosthetic
valve situated within the mitral valve annulus and within the
atrium (e.g., atrial anchoring arms 2440).
[0126] In some embodiments, an entire length of at least one
ventricular anchoring leg may be configured to extend in a
non-ventricular direction. For example, at least a portion of the
at least one ventricular anchoring leg may be configured to extend
in an atrial direction. Additionally, or alternatively, at least a
portion of the at least one ventricular anchoring leg may be
configured to extend laterally, in a direction perpendicular to a
ventricular direction. In some embodiments, the entire length of
the at least one ventricular anchoring leg may refer to the leg
portions extending between, and including, proximal leg end 3622
and terminal leg end 2244. In some embodiments, the entire length
of the at least one ventricular anchoring leg may be configured to
extend in a non-ventricular direction when the leg is in a
radially-contracted configuration. For example, as depicted in FIG.
5A, the entire length of ventricular anchoring leg 2240 (including
proximal leg end 3622 and terminal leg end 2244) extends in an
atrial direction when the ventricular anchoring leg is in the
radially-contracted configuration. Additionally, or alternatively,
the entire length of the at least one ventricular anchoring leg may
be configured to extend in a non-ventricular direction when the
ventricular anchoring leg is in a radially-expanded configuration.
For example, as depicted in FIGS. 3C and 5E, the entire length of
ventricular anchoring leg 2240 (including proximal leg end 3622 and
terminal leg end 2244) extends in an atrial direction when the
ventricular anchoring leg is in the radially-expanded
configuration.
[0127] In some embodiments, at least one atrial anchoring arm may
include a first portion configured to extend in an atrial direction
and a second portion configured to extend in a ventricular
direction. For example, FIG. 3B illustrates an exemplary atrial
anchoring arm 2440 having a proximal arm portion 3502, an
intermediate arm portion 3504, and a distal arm portion 3506. In
some embodiments, the proximal arm portion 3502 may be configured
to extend in an atrial direction from arm attachment junction 3202
(not depicted in FIG. 3B). In some embodiments, and as illustrated
in FIG. 3B, the entire length of proximal arm portion 3502 may be
configured to extend in an atrial direction (i.e., in an upward
direction in FIG. 3B). Atrial anchoring arm 2440 may include a bend
at a transition between proximal arm portion 3502 and intermediate
arm portion 3504. As a result, in some embodiments, intermediate
arm portion 3504 may be configured to extend in a ventricular
direction (i.e., in a downward direction in FIG. 3B). Accordingly,
intermediate arm portion 3504 may constitute the second portion of
the at least one atrial anchoring arm in some embodiments. Atrial
anchoring arm 2440 may include a second bend at the transition
between intermediate arm portion 3504 and distal arm portion 3506
(that is, arm portion 3508 illustrated in FIG. 2D). As a result, in
some embodiments, distal arm portion 3506 may be configured to
extend in an atrial direction. In some embodiments, at least one of
the proximal arm portion 3502 and the distal arm portion 3506 may
constitute the first portion of the at least one atrial anchoring
arm.
[0128] In some embodiments, a diameter defined by terminal ends of
the atrial anchoring arms may be at least twice as large as a
diameter of an inlet opening of the inner frame. In some
embodiments, the inlet opening may be an opening or aperture at the
atrial end of the inner frame. For example, in FIG. 2A, inner frame
2400 includes an atrial inlet opening 2032, which may be an opening
at the atrial end of the axial lumen 2022 of annular valve body
2020 (illustrated in FIG. 2B). In some embodiments, the inlet
opening may be configured as an opening or aperture through which
blood or other fluid within the atrium may enter the axial lumen of
the annular valve body. The blood or other fluid may flow along the
axial lumen and exit into the ventricle. In some embodiments, the
inlet opening may be bounded by the inner surface of the atrial end
of the inner frame. For example, in FIG. 2D, atrial inlet opening
2032 may be bounded by inner surface 4020 of atrial end inner frame
junctions 3002, which may form the atrial end of inner frame 2400
and of annular valve body 2020. Longitudinal axis 2800 may extend
through the center of atrial inlet opening 2032.
[0129] In some embodiments, the inlet opening of the inner frame
may have a diameter of between 24 millimeters and 32 millimeters.
For example, length 2520 depicted in FIG. 2D represents the radius
of the atrial inlet opening 2032; accordingly, the diameter of
atrial inlet opening 2032 may be twice as long as radius 2520. In
some embodiments, and without limitation, the inlet opening of the
inner frame may have a diameter of 24 millimeters, 24.5
millimeters, 25 millimeters, 25.5 millimeters, 26 millimeters, 26.5
millimeters, 27 millimeters, 27.5 millimeters, 28 millimeters, 28.5
millimeters, 29 millimeters, 29.5 millimeters, 30 millimeters, 30.5
millimeters, 31 millimeters, 31.5 millimeters, 32 millimeters, or
any other suitable diameter length.
[0130] In some embodiments, the atrial anchoring arms may be
positioned at a regular interval about a circumference of the
exemplary prosthetic valve. For example, FIG. 2E illustrates an
arrangement of atrial anchoring arms 2440 about the circumference
of annular valve body 2020. The terminal ends of the atrial
anchoring arms may form a circumference, which may extend around
the inner frame and the longitudinal axis of the prosthetic valve.
For example, in FIG. 2E, terminal arm ends 2444 may define an
atrial anchoring arm circumference 2640, which may extend about the
inner frame of the exemplary prosthetic valve. In some embodiments,
the diameter of the circumference defined by the terminal arm ends
(e.g., the diameter of atrial anchoring arm circumference 2640 in
FIG. 2E) may be at least twice as large as the diameter of the
inner frame inlet opening (e.g., the diameter of atrial inlet
opening 2032 in FIG. 2D).
[0131] In some embodiments, the radius of the circumference defined
by the terminal arm ends (e.g., the radius of atrial anchoring arm
circumference 2640) may be equal to the radius of the inner frame
inlet opening (e.g., the radius of atrial inlet opening 2032) plus
the length of at least one atrial anchoring arm. In some
embodiments, the length of the at least one atrial anchoring arm
may extend in a direction perpendicular to the longitudinal axis of
the prosthetic valve. For example, in FIG. 2E, length 2580 may
represent the length of the atrial anchoring arms 2440. Because
FIG. 2E illustrates a top plan view of valve frame 2000, length
2580 may be perpendicular to longitudinal axis 2800 in FIG. 2D.
Accordingly, in some embodiments, the radius of atrial anchoring
arm circumference 2640 may be equal to the length of the atrial
inlet opening radius 2520 (illustrated in FIG. 2D) plus the length
2580 of the atrial anchoring arms 2440 (illustrated in FIG.
2E).
[0132] In some embodiments, the atrial anchoring arms may have a
length of between 12 millimeters and 18 millimeters. The length of
the atrial anchoring arms may be a length extending between the
proximal arm end (e.g., proximal arm end 3020) and the terminal arm
end (e.g., terminal arm end 2444), in a direction perpendicular to
the longitudinal axis of the prosthetic valve (as represented by
length 2580 in FIG. 2E). For example, and without limitation, the
atrial anchoring arms may have a length of 12 millimeters, 12.5
millimeters, 13 millimeters, 13.5 millimeters, 14 millimeters, 14.5
millimeters, 15 millimeters, 15.5 millimeters, 16 millimeters, 16.5
millimeters, 17 millimeters, 17.5 millimeters, 18 millimeters, or
any other suitable length.
[0133] In some embodiments, the axial length of the prosthetic
valve may be at least as large as the radius of the inlet opening
of the inner frame. For example, in some embodiments, the axial
length of the prosthetic valve may be approximately two centimeters
or less (i.e., 20 millimeters or less). In addition, in some
embodiments (and as discussed above), the inlet opening of the
inner frame may have a diameter of between 24 millimeters and 32
millimeters. Accordingly, in some embodiments, the inlet opening of
the inner frame may have a radius of between 12 millimeters and 16
millimeters.
[0134] In some embodiments, an axial length of the inner frame may
be at least as large as the radius of the inlet opening of the
inner frame. For example, according to embodiments in which the
prosthetic valve has an axial length of two centimeters or less,
the inlet opening of the inner frame (e.g., atrial inlet opening
2032 illustrated in FIG. 2D) may have a radius of approximately
13.5 millimeters or less, while the annular valve body of the
prosthetic valve (e.g., annular valve body 2020 illustrated in FIG.
2D) may have an axial length of approximately 15 millimeters or
less. Thus, the axial length of the annular valve body of the
prosthetic valve is at least as large as the radius of the inlet
opening of the inner frame. In addition, the inner frame may be
configured to have an axial length equal to the axial length of the
annular valve body. For example, and as illustrated in FIG. 2D,
inner frame 2400 may span the entire axial length of annular valve
body 2020, with the inner frame 2400 and annular valve body 2020
sharing common atrial ends 2024 and ventricular ends 2025.
Accordingly, the axial length of the inner frame may also be at
least as large as the radius of the inlet opening of the inner
frame. For example, according to embodiments in which the
prosthetic valve has an axial length of two centimeters or less,
the inlet opening of the inner frame may have a radius of 13.5
millimeters or less, while the inner frame may have an axial length
of 15 millimeters or less.
[0135] In some embodiments, the exemplary prosthetic valve may
include a plurality of leaflets secured within the inner frame. For
example, FIG. 6C illustrates an embodiment in which leaflets 6602
and 6604 (as well as leaflet 6606, which is not depicted in FIG.
6C) are secured within inner frame 2400. Leaflets 6602, 6604, and
6606 may be configured to regulate blood flow through the lumen
2022 of the prosthetic valve. In some embodiments, at least one of
the leaflets may have a radius of between thirteen millimeters and
fifteen millimeters. For example, according to embodiments in which
the prosthetic valve has an axial length of two centimeters or
less, the annular valve body of the prosthetic valve may have an
atrial inlet opening radius (e.g., radius 2520 illustrated in FIG.
2D) of approximately 13.5 millimeters or less, as well as an axial
length (e.g., height 2530 illustrated in FIG. 2D) of approximately
15 millimeters or less. This configuration of the annular valve
body may permit leaflets 6602, 6604, and 6606 to coapt, and may
also permit the prosthetic valve to have an axial length of
approximately two centimeters or less.
[0136] Accordingly, in some embodiments, the axial length of the
prosthetic valve may be at least as large as the radius of at least
one of the leaflets secured within the inner frame. In the above
example, the prosthetic valve may have an axial length of two
centimeters or less (i.e., 20 millimeters or less), while at least
one of leaflets 6602, 6604, and 6606 may have a radius of between
13 millimeters and 15 millimeters. Additionally, or alternatively,
an axial length of the inner frame may be at least as large as a
radius of at least one of the leaflets secured within the inner
frame. In the above example, the annular valve body may have an
axial length of 15 millimeters or less, while at least one of
leaflets 6602, 6604, and 6606 may have a radius of between 13
millimeters and 15 millimeters. In addition, the inner frame may be
configured to have an axial length equal to the axial length of the
annular valve body. For example, and as illustrated in FIG. 2D,
inner frame 2400 may span the entire axial length of annular valve
body 2020, with the inner frame 2400 and annular valve body 2020
sharing common atrial ends 2024 and ventricular ends 2025.
Accordingly, the inner frame may also have an axial length of 15
millimeters or less.
[0137] In some embodiments, a diameter defined by the terminal ends
of the atrial anchoring arms may be at least 1.2 times larger than
a diameter defined by terminal ends of the ventricular anchoring
legs. For example, as discussed above in reference to FIG. 2E,
terminal arm ends 2444 of the atrial anchoring arms 2440 may define
an atrial anchoring arm circumference 2640, which may extend about
annular valve body 2020. Similarly, the terminal leg ends 2244 of
the ventricular anchoring legs 2240 may define a ventricular
anchoring leg circumference 2620, which may also extend about the
annular valve body 2020 and may be concentric with atrial anchoring
arm circumference 2640. In some embodiments, the diameter of atrial
anchoring arm circumference 2640 may be at least 1.2 times larger
than ventricular anchoring leg circumference 2620.
[0138] In some embodiments, the radius of the circumference defined
by the terminal leg ends (e.g., the radius of ventricular anchoring
leg circumference 2620) may be equal to the radius of the inner
frame inlet opening (e.g., the radius of atrial inlet opening 2032)
plus the length of at least one ventricular anchoring leg. In some
embodiments, the length of the at least one ventricular anchoring
leg may extend in a direction perpendicular to the longitudinal
axis of the prosthetic valve. For example, in FIG. 2E, length 2590
may represent the length of the ventricular anchoring legs 2240.
Because FIG. 2E illustrates a top plan view of valve frame 2000,
length 2590 may be perpendicular to longitudinal axis 2800 in FIG.
2D. Accordingly, in some embodiments, the radius of ventricular
anchoring leg circumference 2620 may be equal to the length of the
atrial inlet opening radius 2520 (illustrated in FIG. 2D) plus the
length 2590 of the ventricular anchoring legs 2240 (illustrated in
FIG. 2E).
[0139] In some embodiments, the ventricular anchoring legs may have
a length of between six (6) millimeters and 12 millimeters. The
length of the ventricular anchoring legs may be a length extending
between the proximal leg end (e.g., proximal leg end 3622) and the
terminal leg end (e.g., terminal leg end 2244), in a direction
perpendicular to the longitudinal axis of the prosthetic valve (as
represented by length 2590 in FIG. 2E). For example, and without
limitation, the ventricular anchoring legs may have a length of 6
millimeters, 6.5 millimeters, 7 millimeters, 7.5 millimeters, 8
millimeters, 8.5 millimeters, 9 millimeters, 9.5 millimeters, 10
millimeters, 10.5 millimeters, 11 millimeters, 11.5 millimeters, 12
millimeters, or any other suitable length.
[0140] In some embodiments, a diameter defined by the terminal ends
of the atrial anchoring arms may be at least 2.5 times larger than
the axial length of the prosthetic valve. For example, and as
discussed above, the prosthetic valve may be configured to have an
axial length of two centimeters (20 millimeters) or less, in some
embodiments. The prosthetic valve may be configured to have such a
short axial length due, at least in part, to the small radius of
the annular valve body of the prosthetic valve. In addition, due to
the small radius of the annular valve body, the atrial anchoring
arms may be configured so that the terminal ends of the atrial
anchoring arms may form an outer circumference large enough to keep
the prosthetic valve anchored within the native heart valve. That
is, the circumference formed by the terminal arm ends may have a
diameter large enough to prevent the prosthetic valve from axially
migrating out of the native valve annulus (e.g., preventing the
prosthetic valve from floating out of mitral valve 9030 and into
ventricle 9020).
[0141] In some embodiments, the circumference defined by the
terminal arm ends of the atrial anchoring arms (e.g., the atrial
anchoring arm circumference 2640 in FIG. 2E) may have a diameter of
between 50 millimeters and 65 millimeters. For example, and without
limitation, the diameter defined by the terminal ends of the atrial
anchoring arms may have a length of 50 millimeters, 50.5
millimeters, 51 millimeters, 51.5 millimeters, 52 millimeters, 52.5
millimeters, 53 millimeters, 53.5 millimeters, 54 millimeters, 54.5
millimeters, 55 millimeters, 55.5 millimeters, 56 millimeters, 56.5
millimeters, 57 millimeters, 57.5 millimeters, 58 millimeters, 58.5
millimeters, 59 millimeters, 59.5 millimeters, 60 millimeters, 60.5
millimeters, 61 millimeters, 61.5 millimeters, 62 millimeters, 62.5
millimeters, 63 millimeters, 63.5 millimeters, 64 millimeters, 64.5
millimeters, 65 millimeters, or any other suitable diameter length.
Advantageously, the large circumference defined by the distal arm
ends may enable to atrial anchoring arms to engage a large
circumference of tissue around the native heart valve, thus
securing the prosthetic valve against axial migration relative to
the native heart valve.
[0142] In some embodiments, the diameter defined by the terminal
ends of the atrial anchoring arms may be between 2.6 and 2.9 times
larger than the axial length of the prosthetic valve. For example,
in the embodiments discussed above, the prosthetic valve may have
an axial length of two centimeters (20 millimeters) or less, and a
circumference defined by the terminal ends of the atrial anchoring
arms may include, and is not limited to, a diameter of between 52
millimeters and 58 millimeters.
[0143] In some embodiments, the inner frame may have an axial
length longer than an axial length of the annular outer frame,
relative to the longitudinal axis of the exemplary prosthetic
valve. In some embodiments, the inner frame, including the inner
frame tubular portion and the plurality of atrial anchoring arms,
may have a greater axial length than the outer frame, including the
outer frame tubular portion and the plurality of ventricular
anchoring legs. For example, in the embodiment depicted in FIG. 2D,
device height 2560 may represent the axial length of inner frame
2400, including inner frame tubular portion 3005 and atrial
anchoring arms 2440. Similarly, outer frame height 2550 may
represent the axial length of outer frame 2200, including outer
frame tubular portion 3605 and ventricular anchoring legs 2240. As
illustrated in FIG. 2D, device height 2560 may be greater than
outer frame height 2550.
[0144] Additionally, or alternatively, the inner frame tubular
portion may have a greater axial length than the outer frame
tubular portion, relative to the longitudinal axis of the exemplary
prosthetic valve. In some embodiments, the inner frame tubular
portion and outer frame tubular portion may together constitute the
annular valve body. For example, in the embodiment depicted in FIG.
2D, inner frame tubular portion height 2530 may represent the axial
length of inner frame tubular portion 3005. Inner frame tubular
portion height 2530 may extend axially between atrial end inner
frame junctions 3002 and ventricular end inner frame junctions
3004. Similarly, outer frame tubular portion height 2570 may
represent the axial length of outer frame tubular portion 3605.
Outer frame tubular portion height 2570 may extend axially between
atrial end outer frame junctions 3602 and ventricular end outer
frame junctions 3604. As illustrated in FIG. 2D, inner frame
tubular portion height 2530 may be greater than outer frame tubular
portion height 2570.
[0145] In some embodiments, the ventricular ends of the inner frame
and outer frame may be substantially aligned in a common lateral
plane; that is, the ventricular ends of the inner frame and outer
frame may be arranged at the same axial position relative to the
longitudinal axis of the prosthetic valve. For example, in FIG. 2D,
ventricular end inner frame junctions 3004 may be substantially
aligned in a common lateral plane with ventricular end outer frame
junctions 3604. Further, the atrial end of the inner frame may
extend in an atrial direction beyond the atrial end of the outer
frame (that is, the atrial end of the inner frame may be positioned
above the atrial end of the outer frame in FIG. 2D). For example,
in FIG. 2D, the atrial end inner frame junctions 3002 may be
positioned in an atrial direction from the atrial end outer frame
junctions 3602.
[0146] In some embodiments, at least a portion of at least one
ventricular anchoring leg may be configured to be substantially
aligned in a common lateral plane with the atrial end of the inner
frame. That is, a portion of the at least one ventricular anchoring
leg and the atrial end of the inner frame may be arranged at the
same axial position relative to the longitudinal axis of the
prosthetic valve. In some embodiments, the terminal end of the at
least one ventricular anchoring leg (e.g., terminal leg end 2244)
may be arranged in a common lateral plane with the atrial end of
the inner frame (e.g., atrial end inner frame junctions 3002).
Additionally, or alternatively, another portion of the at least one
ventricular anchoring leg may be arranged in a common lateral plane
with the atrial end of the inner frame.
[0147] In some embodiments, at least one ventricular anchoring leg
may be configured to extend from a single portion of the annular
outer frame. For example, each ventricular anchoring leg may be
connected to, or may otherwise extend from, a single portion of the
annular outer frame. For example, in FIG. 2A, each ventricular
anchoring leg 2240 may be connected to the annular outer frame 2200
at a single leg attachment junction 3802. Additionally, or
alternatively, none of the ventricular anchoring legs may share a
common connection point to the annular outer frame. For example, in
FIG. 2A, each leg attachment junction 3802 of the annular outer
frame 2200 may be connected to a single ventricular anchoring leg
2240.
[0148] In some embodiments, at least one atrial anchoring arm may
be configured to extend from a single portion of the inner frame.
For example, each atrial anchoring arm may be connected to, or may
otherwise extend from, a single portion of the inner frame. For
example, in FIG. 2A, each atrial anchoring arm 2440 may be
connected to the inner frame 2400 at a single arm attachment
junction 3202. Additionally, or alternatively, none of the atrial
anchoring arms may share a common connection point to the inner
frame. For example, in FIG. 2A, each arm attachment junction 3202
of the inner frame 2400 may be connected to a single atrial
anchoring arm 2440.
[0149] The foregoing description has been presented for purposes of
illustration. It is not exhaustive and is not limited to precise
forms or embodiments disclosed. Modifications and adaptations of
the embodiments will be apparent from consideration of the
specification and practice of the disclosed embodiments. For
example, while certain components have been described as being
coupled to one another, such components may be integrated with one
another or distributed in any suitable fashion.
[0150] Moreover, while illustrative embodiments have been described
herein, the scope includes any and all embodiments having
equivalent elements, modifications, omissions, combinations (e.g.,
of aspects across various embodiments), adaptations and/or
alterations based on the present disclosure. The elements in the
claims are to be interpreted broadly based on the language employed
in the claims and not limited to examples described in the present
specification or during the prosecution of the application, which
examples are to be construed as nonexclusive. Further, the steps of
the disclosed methods can be modified in any manner, including
reordering steps and/or inserting or deleting steps.
[0151] The features and advantages of the disclosure are apparent
from the detailed specification, and thus, it is intended that the
appended claims cover all systems and methods falling within the
true spirit and scope of the disclosure. As used herein, the
indefinite articles "a" and "an" mean "one or more." Similarly, the
use of a plural term does not necessarily denote a plurality unless
it is unambiguous in the given context. Words such as "and" or "or"
mean "and/or" unless specifically directed otherwise. Further,
since numerous modifications and variations will readily occur from
studying the present disclosure, it is not desired to limit the
disclosure to the exact construction and operation illustrated and
described, and, accordingly, all suitable modifications and
equivalents may be resorted to, falling within the scope of the
disclosure.
[0152] Other embodiments will be apparent from consideration of the
specification and practice of the embodiments disclosed herein. It
is intended that the specification and examples be considered as
example only, with a true scope and spirit of the disclosed
embodiments being indicated by the following claims.
* * * * *